| 2026-07-13 |
Class II
|
Ongoing |
Z-2976-2026 |
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL |
— |
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measureme… |
| 2026-07-13 |
Class II
|
Ongoing |
Z-2975-2026 |
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL |
— |
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measureme… |
| 2026-07-06 |
Class II
|
Ongoing |
Z-2890-2026 |
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic |
— |
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depr… |
| 2026-06-26 |
Class III
|
Ongoing |
Z-2881-2026 |
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL |
— |
out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not imp… |
| 2026-06-26 |
Class III
|
Ongoing |
Z-2880-2026 |
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL |
— |
Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the o… |
| 2026-06-08 |
Class II
|
Ongoing |
Z-2703-2026 |
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. |
— |
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely e… |
| 2026-05-07 |
Class II
|
Ongoing |
Z-2398-2026 |
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay |
— |
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge. |
| 2026-04-02 |
Class II
|
Ongoing |
Z-2005-2026 |
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; |
— |
Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, v… |
| 2026-03-18 |
Class II
|
Ongoing |
Z-1980-2026 |
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. |
— |
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the … |
| 2026-02-23 |
Class II
|
Ongoing |
Z-1657-2026 |
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536; |
— |
A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate a… |
| 2026-01-20 |
Class II
|
Ongoing |
Z-1484-2026 |
Atellica CH Urine Albumin (UAlb). Material Number: 11537225 |
— |
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may repo… |
| 2025-10-06 |
Class II
|
Ongoing |
Z-0493-2026 |
Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4; |
— |
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 20… |
| 2025-10-06 |
Class II
|
Ongoing |
Z-0492-2026 |
3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Speci… |
— |
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 20… |
| 2025-10-06 |
Class II
|
Ongoing |
Z-0491-2026 |
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6; |
— |
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 20… |
| 2025-09-22 |
Class II
|
Ongoing |
Z-0366-2026 |
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog N… |
— |
The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol… |
| 2025-08-11 |
Class II
|
Ongoing |
Z-2542-2025 |
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543. |
— |
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results. |
| 2025-07-07 |
Class II
|
Ongoing |
Z-2272-2025 |
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. |
— |
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intend… |
| 2025-06-26 |
Class II
|
Ongoing |
Z-2230-2025 |
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. |
— |
Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negat… |
| 2025-06-04 |
Class II
|
Ongoing |
Z-2089-2025 |
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control) |
— |
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. |
| 2025-06-04 |
Class II
|
Ongoing |
Z-2088-2025 |
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) |
— |
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. |
| 2025-06-04 |
Class II
|
Ongoing |
Z-2087-2025 |
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) |
— |
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. |
| 2025-06-04 |
Class II
|
Ongoing |
Z-2086-2025 |
ADVIA¿ 120/2120/2120i SETpoint Calibrator |
— |
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. |
| 2025-05-22 |
Class II
|
Ongoing |
Z-2027-2025 |
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300; |
— |
Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sod… |
| 2025-04-15 |
Class II
|
Ongoing |
Z-1822-2025 |
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376. |
— |
Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to … |
| 2025-04-15 |
Class II
|
Ongoing |
Z-1821-2025 |
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498 |
— |
Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to … |
| 2025-03-31 |
Class II
|
Ongoing |
Z-1673-2025 |
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma. |
— |
Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal.… |
| 2025-03-19 |
Class II
|
Ongoing |
Z-1685-2025 |
epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Softw… |
— |
The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n. |
| 2025-03-19 |
Class II
|
Ongoing |
Z-1684-2025 |
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Softwa… |
— |
The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n. |
| 2025-03-11 |
Class II
|
Ongoing |
Z-1551-2025 |
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223. |
— |
Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result. |
| 2024-11-22 |
Class II
|
Ongoing |
Z-0741-2025 |
epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by tra… |
— |
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that c… |
| 2024-11-22 |
Class II
|
Ongoing |
Z-0740-2025 |
epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by… |
— |
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that c… |
| 2024-11-22 |
Class II
|
Ongoing |
Z-0739-2025 |
epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by t… |
— |
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that c… |
| 2024-11-22 |
Class II
|
Ongoing |
Z-0738-2025 |
epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by tra… |
— |
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that c… |
| 2024-11-22 |
Class II
|
Ongoing |
Z-0737-2025 |
epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by tra… |
— |
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that c… |
| 2024-11-22 |
Class II
|
Ongoing |
Z-0736-2025 |
epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by tra… |
— |
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that c… |
| 2024-11-22 |
Class II
|
Ongoing |
Z-0735-2025 |
epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by tra… |
— |
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that c… |
| 2024-11-22 |
Class II
|
Ongoing |
Z-0734-2025 |
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by train… |
— |
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that c… |
| 2024-11-12 |
Class II
|
Ongoing |
Z-0767-2025 |
Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158; |
— |
Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista¿ Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to th… |
| 2024-11-04 |
Class II
|
Ongoing |
Z-0597-2025 |
Atellica CI Analyzer. Catalog Numbers: 10947347. |
— |
Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent … |
| 2024-10-21 |
Class II
|
Ongoing |
Z-0599-2025 |
Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in h… |
— |
Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH ¿2-Mi… |
| 2024-10-21 |
Class II
|
Ongoing |
Z-0496-2025 |
Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and… |
— |
A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment… |
| 2024-09-30 |
Class II
|
Ongoing |
Z-0464-2025 |
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282) |
— |
The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructi… |
| 2024-09-24 |
Class II
|
Ongoing |
Z-0286-2025 |
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515 |
— |
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to e… |
| 2024-08-21 |
Class II
|
Ongoing |
Z-3305-2024 |
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test) |
— |
Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM … |
| 2024-08-21 |
Class II
|
Ongoing |
Z-3304-2024 |
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test) |
— |
Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM … |
| 2024-08-15 |
Class II
|
Ongoing |
Z-3170-2024 |
ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in … |
— |
Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stat… |
| 2024-08-15 |
Class II
|
Ongoing |
Z-3169-2024 |
Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human… |
— |
Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stat… |
| 2024-07-30 |
Class II
|
Ongoing |
Z-3065-2024 |
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146; |
— |
During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an is… |
| 2024-07-29 |
Class II
|
Ongoing |
Z-3064-2024 |
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151 |
— |
The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents. |
| 2024-07-29 |
Class II
|
Ongoing |
Z-3063-2024 |
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543 |
— |
The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents. |
| 2024-07-26 |
Class II
|
Ongoing |
Z-3104-2024 |
ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated… |
— |
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the … |
| 2024-07-26 |
Class II
|
Ongoing |
Z-3103-2024 |
ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated … |
— |
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the … |
| 2024-07-26 |
Class II
|
Ongoing |
Z-3102-2024 |
Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associ… |
— |
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the … |
| 2024-07-26 |
Class II
|
Ongoing |
Z-3101-2024 |
Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated … |
— |
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the … |
| 2024-07-26 |
Class II
|
Ongoing |
Z-3100-2024 |
Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated an… |
— |
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the … |
| 2024-05-17 |
Class II
|
Ongoing |
Z-2214-2024 |
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e… |
— |
Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the … |
| 2024-04-23 |
Class II
|
Ongoing |
Z-1887-2024 |
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody. |
— |
The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab. |
| 2024-04-23 |
Class II
|
Ongoing |
Z-1886-2024 |
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody. |
— |
The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 … |
| 2024-03-13 |
Class II
|
Ongoing |
Z-1549-2024 |
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodiu… |
— |
Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. … |
| 2024-02-07 |
Class II
|
Ongoing |
Z-1304-2024 |
DCA Systems HbA1c Reagent Kit |
— |
The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of … |
| 2024-01-24 |
Class II
|
Ongoing |
Z-1281-2024 |
ADVIA Centaur Erythropoietin (EPO) Assay (100 Test) |
— |
Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC … |
| 2024-01-24 |
Class II
|
Ongoing |
Z-1280-2024 |
Atellica IM Erythropoietin (EPO) Assay (100 Test) |
— |
Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC … |
| 2023-12-15 |
Class II
|
Ongoing |
Z-1003-2024 |
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry |
— |
Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent. |
| 2023-10-26 |
Class II
|
Ongoing |
Z-0609-2024 |
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to … |
— |
RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in… |
| 2023-10-26 |
Class II
|
Ongoing |
Z-0608-2024 |
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to … |
— |
RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in… |
| 2023-10-26 |
Class II
|
Ongoing |
Z-0607-2024 |
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to … |
— |
RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in… |
| 2023-10-26 |
Class II
|
Ongoing |
Z-0606-2024 |
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed t… |
— |
RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in… |
| 2023-10-19 |
Class II
|
Ongoing |
Z-0601-2024 |
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX)… |
— |
Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results t… |
| 2023-09-26 |
Class II
|
Ongoing |
Z-0423-2024 |
RAPIDPOINT 500 Blood Gas System |
— |
There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPI… |
| 2023-09-26 |
Class II
|
Ongoing |
Z-0422-2024 |
RAPIDPOINT 500e Blood Gas System |
— |
There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPI… |
| 2023-08-08 |
Class II
|
Ongoing |
Z-2666-2023 |
ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests) |
— |
There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, t… |
| 2023-07-25 |
Class II
|
Ongoing |
Z-2451-2023 |
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the qu… |
— |
There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE… |
| 2023-07-10 |
Class II
|
Ongoing |
Z-2474-2023 |
Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human se… |
— |
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator resu… |
| 2023-07-10 |
Class II
|
Ongoing |
Z-2473-2023 |
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl tran… |
— |
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator resu… |
| 2023-07-10 |
Class II
|
Ongoing |
Z-2472-2023 |
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human seru… |
— |
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator resu… |
| 2023-07-10 |
Class II
|
Ongoing |
Z-2471-2023 |
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human se… |
— |
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator resu… |
| 2023-06-01 |
Class II
|
Ongoing |
Z-2478-2023 |
epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1 |
— |
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. |
| 2023-06-01 |
Class II
|
Ongoing |
Z-2477-2023 |
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1 |
— |
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. |
| 2023-06-01 |
Class II
|
Ongoing |
Z-2476-2023 |
epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1 |
— |
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. |
| 2023-05-16 |
Class II
|
Ongoing |
Z-2091-2023 |
Aptio Automation Storage and Retrieval Module (SRM) |
— |
A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of … |
| 2023-04-05 |
Class II
|
Ongoing |
Z-1632-2023 |
Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic … |
— |
Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a… |
| 2023-04-05 |
Class II
|
Ongoing |
Z-1631-2023 |
ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), ac… |
— |
Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a… |
| 2023-03-16 |
Class II
|
Ongoing |
Z-1505-2023 |
ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA… |
— |
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low. |
| 2023-03-16 |
Class II
|
Ongoing |
Z-1504-2023 |
Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 1120… |
— |
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low. |
| 2023-01-30 |
Class II
|
Ongoing |
Z-1258-2023 |
Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimu… |
— |
Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lot… |
| 2023-01-27 |
Class II
|
Ongoing |
Z-1271-2023 |
Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum a… |
— |
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results |
| 2023-01-27 |
Class II
|
Ongoing |
Z-1270-2023 |
Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in hum… |
— |
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results |
| 2023-01-27 |
Class II
|
Ongoing |
Z-1269-2023 |
Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum … |
— |
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results |
| 2023-01-27 |
Class II
|
Ongoing |
Z-1268-2023 |
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human ser… |
— |
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results |
| 2023-01-09 |
Class II
|
Ongoing |
Z-1154-2023 |
ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human… |
— |
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| 2023-01-09 |
Class II
|
Ongoing |
Z-1153-2023 |
ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human seru… |
— |
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| 2023-01-09 |
Class II
|
Ongoing |
Z-1152-2023 |
ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum… |
— |
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| 2023-01-09 |
Class II
|
Ongoing |
Z-1151-2023 |
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human s… |
— |
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| 2023-01-09 |
Class II
|
Ongoing |
Z-1150-2023 |
Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum … |
— |
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| 2023-01-09 |
Class II
|
Ongoing |
Z-1149-2023 |
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum … |
— |
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| 2022-12-22 |
Class II
|
Ongoing |
Z-1143-2023 |
ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detect… |
— |
Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that… |
| 2022-12-12 |
Class II
|
Ongoing |
Z-1215-2023 |
epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc… |
— |
pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure |
| 2022-12-12 |
Class II
|
Ongoing |
Z-1214-2023 |
epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, C… |
— |
pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure |
| 2022-12-07 |
Class II
|
Ongoing |
Z-0950-2023 |
IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quanti… |
— |
Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; … |
| 2022-12-07 |
Class II
|
Ongoing |
Z-0949-2023 |
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ … |
— |
Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges;… |
| 2022-11-04 |
Class II
|
Ongoing |
Z-0718-2023 |
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For… |
— |
Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result |
| 2022-11-04 |
Class II
|
Ongoing |
Z-0717-2023 |
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 103… |
— |
Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result |
| 2022-11-04 |
Class II
|
Ongoing |
Z-0716-2023 |
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 … |
— |
Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result |
| 2022-10-25 |
Class II
|
Ongoing |
Z-0355-2023 |
IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyze… |
— |
Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000 Tot… |
| 2022-09-19 |
Class II
|
Ongoing |
Z-0105-2023 |
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay |
— |
Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium p… |
| 2022-09-19 |
Class II
|
Ongoing |
Z-0104-2023 |
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay |
— |
Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium p… |
| 2022-08-30 |
Class II
|
Ongoing |
Z-0094-2023 |
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 104… |
— |
N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF). |
| 2022-08-30 |
Class II
|
Ongoing |
Z-0093-2023 |
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 1044629… |
— |
N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF). |
| 2022-08-24 |
Class II
|
Ongoing |
Z-0089-2023 |
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): … |
— |
Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Re… |
| 2022-08-17 |
Class II
|
Ongoing |
Z-1816-2022 |
Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57 |
— |
Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not al… |
| 2022-08-11 |
Class II
|
Ongoing |
Z-1820-2022 |
IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 U… |
— |
An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there i… |
| 2022-07-18 |
Class II
|
Ongoing |
Z-1648-2022 |
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. … |
— |
Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisio… |
| 2022-06-28 |
Class II
|
Ongoing |
Z-1498-2022 |
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and… |
— |
Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test i… |
| 2022-06-01 |
Class II
|
Ongoing |
Z-1372-2022 |
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinize… |
— |
Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support. |
| 2022-05-18 |
Class II
|
Terminated |
Z-1341-2022 |
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and he… |
— |
Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to ina… |
| 2022-05-18 |
Class II
|
Terminated |
Z-1340-2022 |
Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and h… |
— |
Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to ina… |
| 2022-04-13 |
Class II
|
Ongoing |
Z-1253-2022 |
Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical sp… |
— |
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results |
| 2022-04-13 |
Class II
|
Ongoing |
Z-1252-2022 |
Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical sp… |
— |
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results |
| 2022-03-03 |
Class II
|
Ongoing |
Z-1025-2022 |
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol S… |
— |
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| 2022-03-03 |
Class II
|
Ongoing |
Z-1024-2022 |
ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN… |
— |
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| 2022-03-03 |
Class II
|
Ongoing |
Z-1023-2022 |
ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN… |
— |
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| 2022-03-03 |
Class II
|
Ongoing |
Z-1022-2022 |
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol… |
— |
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| 2022-03-03 |
Class II
|
Ongoing |
Z-1021-2022 |
Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: … |
— |
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| 2022-03-03 |
Class II
|
Ongoing |
Z-1020-2022 |
Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: … |
— |
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| 2022-02-22 |
Class II
|
Ongoing |
Z-1015-2022 |
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10… |
— |
Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors. |
| 2022-02-09 |
Class II
|
Ongoing |
Z-0931-2022 |
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637 |
— |
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. |
| 2022-02-09 |
Class II
|
Ongoing |
Z-0930-2022 |
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637 |
— |
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. |
| 2022-02-09 |
Class II
|
Ongoing |
Z-0929-2022 |
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536 |
— |
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. |
| 2022-02-09 |
Class II
|
Ongoing |
Z-0928-2022 |
Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644 |
— |
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. |
| 2022-01-28 |
Class II
|
Ongoing |
Z-0830-2022 |
Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimensio… |
— |
Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential… |
| 2021-12-01 |
Class II
|
Terminated |
Z-0440-2022 |
Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microgl… |
— |
¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concen… |
| 2021-11-18 |
Class II
|
Ongoing |
Z-0449-2022 |
Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to… |
— |
(1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test … |
| 2021-10-15 |
Class II
|
Terminated |
Z-0331-2022 |
Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mi… |
— |
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays |
| 2021-10-15 |
Class II
|
Terminated |
Z-0330-2022 |
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mi… |
— |
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays |
| 2021-10-06 |
Class II
|
Ongoing |
Z-0193-2022 |
Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1… |
— |
The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. I… |
| 2021-09-28 |
Class II
|
Ongoing |
Z-0125-2022 |
Atellica IM 1600 Analyzer, SMN 11066000 |
— |
Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater… |
| 2021-09-28 |
Class II
|
Ongoing |
Z-0124-2022 |
Atellica IM 1300 Analyzer, SMN 11066001 |
— |
Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater… |
| 2021-09-22 |
Class II
|
Terminated |
Z-0196-2022 |
ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866 |
— |
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use. |
| 2021-09-22 |
Class II
|
Terminated |
Z-0195-2022 |
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861 |
— |
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use. |
| 2021-09-20 |
Class II
|
Ongoing |
Z-0181-2022 |
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151 |
— |
The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c… |
| 2021-09-20 |
Class II
|
Ongoing |
Z-0180-2022 |
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543 |
— |
The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM)… |
| 2021-07-06 |
Class II
|
Ongoing |
Z-2426-2021 |
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determinati… |
— |
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for a… |
| 2021-07-06 |
Class II
|
Ongoing |
Z-2425-2021 |
Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer… |
— |
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for a… |
| 2021-07-06 |
Class II
|
Ongoing |
Z-2424-2021 |
Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer… |
— |
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for a… |
| 2021-05-18 |
Class II
|
Terminated |
Z-2014-2021 |
The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry an… |
— |
ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current defau… |
| 2021-05-13 |
Class II
|
Ongoing |
Z-2028-2021 |
Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000 |
— |
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in th… |
| 2021-05-13 |
Class II
|
Ongoing |
Z-2027-2021 |
Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001 |
— |
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in th… |
| 2021-05-13 |
Class II
|
Ongoing |
Z-2026-2021 |
Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000 |
— |
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in th… |
| 2021-05-04 |
Class II
|
Ongoing |
Z-1870-2021 |
Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000 |
— |
Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results |
| 2021-04-21 |
Class II
|
Ongoing |
Z-1674-2021 |
Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination o… |
— |
Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used im… |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1405-2021 |
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6… |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1404-2021 |
ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software Ver… |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1403-2021 |
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11 |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1402-2021 |
ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.… |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1401-2021 |
ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and… |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1400-2021 |
ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software Versions 6… |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1399-2021 |
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.1… |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1398-2021 |
ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.1… |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1397-2021 |
ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and … |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1396-2021 |
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.… |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1395-2021 |
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions … |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1394-2021 |
ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Ver… |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1393-2021 |
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11 |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1392-2021 |
ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.… |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1391-2021 |
ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions 6.10 and… |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1390-2021 |
ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.… |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1389-2021 |
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.1… |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1388-2021 |
ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated hematology analyzer … |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1387-2021 |
ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology analyz… |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1386-2021 |
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 a… |
— |
Potential Sample Identification (SID) Mismatch with14-Character Barcodes |
| 2021-03-02 |
Class II
|
Terminated |
Z-1435-2021 |
BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Produc… |
— |
Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples. |
| 2021-02-08 |
Class II
|
Terminated |
Z-1274-2021 |
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2 |
— |
Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and… |
| 2021-02-03 |
Class II
|
Ongoing |
Z-1188-2021 |
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disor… |
— |
Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vist… |
| 2020-12-02 |
Class II
|
Terminated |
Z-0863-2021 |
Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11… |
— |
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results |
| 2020-12-02 |
Class II
|
Terminated |
Z-0862-2021 |
Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11… |
— |
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results |
| 2020-12-02 |
Class II
|
Terminated |
Z-0861-2021 |
Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 110… |
— |
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results |
| 2020-11-23 |
Class II
|
Ongoing |
Z-0722-2021 |
Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative deter… |
— |
Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performanc… |
| 2020-11-23 |
Class II
|
Ongoing |
Z-0721-2021 |
ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determin… |
— |
Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performanc… |
| 2020-10-26 |
Class II
|
Terminated |
Z-0474-2021 |
Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic test… |
— |
Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef ver… |
| 2020-10-26 |
Class II
|
Terminated |
Z-0473-2021 |
Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic test… |
— |
Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of… |
| 2020-09-22 |
Class II
|
Ongoing |
Z-0102-2021 |
Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein … |
— |
Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potentia… |
| 2020-09-22 |
Class II
|
Ongoing |
Z-0101-2021 |
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated prot… |
— |
Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potentia… |
| 2020-08-28 |
Class II
|
Terminated |
Z-2970-2020 |
Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anti… |
— |
Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessa… |
| 2020-08-25 |
Class II
|
Terminated |
Z-0134-2021 |
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitati… |
— |
Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27… |
| 2020-08-25 |
Class II
|
Terminated |
Z-0115-2021 |
Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)… |
— |
Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false… |
| 2020-08-19 |
Class II
|
Terminated |
Z-0052-2021 |
Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitativ… |
— |
Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples us… |
| 2020-07-24 |
Class II
|
Terminated |
Z-2927-2020 |
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitativ… |
— |
Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples |
| 2020-06-30 |
Class II
|
Terminated |
Z-2747-2020 |
DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Ana… |
— |
If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirming the integrity of read barcode data using the check digit. … |
| 2020-06-05 |
Class II
|
Terminated |
Z-2431-2020 |
Atellica CH Chemistry Calibrator |
— |
Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 f… |
| 2020-06-05 |
Class II
|
Terminated |
Z-2430-2020 |
ADVIA Chemistry Calibrator |
— |
Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 f… |
| 2020-05-27 |
Class II
|
Terminated |
Z-2432-2020 |
RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778 |
— |
The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes. |
| 2020-05-15 |
Class II
|
Terminated |
Z-2470-2020 |
Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended f… |
— |
Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, c… |
| 2020-05-15 |
Class II
|
Terminated |
Z-2469-2020 |
Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for p… |
— |
Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, c… |
| 2020-05-15 |
Class II
|
Terminated |
Z-2438-2020 |
(1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager softw… |
— |
Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patien… |
| 2020-05-15 |
Class II
|
Terminated |
Z-2437-2020 |
(1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Da… |
— |
Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient … |
| 2020-05-07 |
Class II
|
Ongoing |
Z-2405-2020 |
Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026 |
— |
Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1… |
| 2020-05-07 |
Class II
|
Ongoing |
Z-2404-2020 |
Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960 |
— |
Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600 analy… |
| 2020-05-04 |
Class II
|
Terminated |
Z-2285-2020 |
Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use i… |
— |
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient sa… |
| 2020-05-04 |
Class II
|
Terminated |
Z-2284-2020 |
Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the … |
— |
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient sa… |
| 2020-05-04 |
Class II
|
Terminated |
Z-2283-2020 |
Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in … |
— |
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient sa… |
| 2020-05-04 |
Class II
|
Terminated |
Z-2282-2020 |
ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use… |
— |
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient sa… |
| 2020-05-04 |
Class II
|
Terminated |
Z-2281-2020 |
Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantita… |
— |
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient sa… |
| 2020-05-04 |
Class II
|
Terminated |
Z-2280-2020 |
ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage… |
— |
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient sa… |
| 2020-02-27 |
Class II
|
Terminated |
Z-1797-2020 |
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower |
— |
Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may c… |
| 2020-02-14 |
Class II
|
Terminated |
Z-1599-2020 |
Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an… |
— |
The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval. |
| 2020-02-13 |
Class II
|
Terminated |
Z-1541-2020 |
Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total bilirubi… |
— |
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
| 2020-02-13 |
Class II
|
Terminated |
Z-1540-2020 |
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: … |
— |
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
| 2020-02-13 |
Class II
|
Terminated |
Z-1539-2020 |
ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is … |
— |
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
| 2020-02-13 |
Class II
|
Terminated |
Z-1538-2020 |
ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for… |
— |
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
| 2020-02-13 |
Class II
|
Terminated |
Z-1537-2020 |
Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Produ… |
— |
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
| 2020-02-13 |
Class II
|
Terminated |
Z-1536-2020 |
Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Prod… |
— |
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
| 2020-02-05 |
Class II
|
Terminated |
Z-1514-2020 |
IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 t… |
— |
Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinte… |
| 2020-02-05 |
Class II
|
Terminated |
Z-1513-2020 |
IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use … |
— |
Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinte… |
| 2020-01-12 |
Class II
|
Ongoing |
Z-1421-2020 |
Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143 |
— |
Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which ma… |
| 2020-01-06 |
Class II
|
Terminated |
Z-1436-2020 |
Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage:… |
— |
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. |
| 2020-01-06 |
Class II
|
Terminated |
Z-1435-2020 |
Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage:… |
— |
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. |