| 2026-07-15 |
Class II
|
Ongoing |
Z-2974-2026 |
Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Numbe… |
— |
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the… |
| 2026-07-15 |
Class II
|
Ongoing |
Z-2973-2026 |
Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, D… |
— |
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the… |
| 2026-06-26 |
Class II
|
Ongoing |
Z-2889-2026 |
REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan … |
— |
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." |
| 2026-06-26 |
Class II
|
Ongoing |
Z-2888-2026 |
REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018… |
— |
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." |
| 2026-03-16 |
Class II
|
Ongoing |
Z-1922-2026 |
Access Total T4 Calibrator, Catalog No. 33805 |
— |
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product s… |
| 2025-12-23 |
Class II
|
Ongoing |
Z-1235-2026 |
CellMek SPS Sample Preparation System, REF: C44603, with software |
— |
Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube… |
| 2025-11-26 |
Class II
|
Ongoing |
Z-1026-2026 |
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit |
— |
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdo… |
| 2025-11-26 |
Class II
|
Ongoing |
Z-1025-2026 |
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit |
— |
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdo… |
| 2025-11-10 |
Class II
|
Ongoing |
Z-1221-2026 |
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjun… |
— |
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers. |
| 2025-11-07 |
Class II
|
Ongoing |
Z-0889-2026 |
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibratio… |
— |
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may h… |
| 2025-10-01 |
Class II
|
Ongoing |
Z-0429-2026 |
Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer |
— |
An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause… |
| 2025-10-01 |
Class II
|
Ongoing |
Z-0428-2026 |
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer |
— |
An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause… |
| 2025-09-22 |
Class II
|
Ongoing |
Z-0541-2026 |
DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for us… |
— |
Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed pati… |
| 2025-09-19 |
Class II
|
Ongoing |
Z-0216-2026 |
DxI 9000 Access Immunoassay Analyzer, Part Number C11137 |
— |
Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application… |
| 2025-09-19 |
Class II
|
Ongoing |
Z-0215-2026 |
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i … |
— |
Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application… |
| 2025-09-17 |
Class II
|
Ongoing |
Z-0441-2026 |
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 |
— |
Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate… |
| 2025-09-08 |
Class II
|
Ongoing |
Z-1794-2026 |
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan … |
— |
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0412-2026 |
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU… |
— |
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassett… |
| 2025-09-03 |
Class II
|
Ongoing |
Z-0071-2026 |
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only. |
— |
Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay … |
| 2025-08-13 |
Class II
|
Ongoing |
Z-2575-2025 |
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858 |
— |
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) cou… |
| 2025-08-13 |
Class II
|
Ongoing |
Z-2574-2025 |
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322 |
— |
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) cou… |
| 2025-08-13 |
Class II
|
Ongoing |
Z-2573-2025 |
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520 |
— |
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) cou… |
| 2025-08-13 |
Class II
|
Ongoing |
Z-2572-2025 |
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478 |
— |
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) cou… |
| 2025-08-04 |
Class II
|
Ongoing |
Z-0032-2026 |
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part … |
— |
On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed betwe… |
| 2025-07-24 |
Class II
|
Ongoing |
Z-1609-2026 |
MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining ant… |
— |
Due to the likely presence of contamination in well(s). |
| 2025-07-10 |
Class II
|
Ongoing |
Z-2322-2025 |
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860 |
— |
Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pu… |
| 2025-06-26 |
Class II
|
Ongoing |
Z-2264-2025 |
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205, |
— |
Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant… |
| 2025-06-25 |
Class II
|
Ongoing |
Z-2271-2025 |
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460 |
— |
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-mot… |
| 2025-06-25 |
Class II
|
Ongoing |
Z-2270-2025 |
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461 |
— |
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-mot… |
| 2025-06-25 |
Class II
|
Ongoing |
Z-2269-2025 |
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260 |
— |
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-mot… |
| 2025-06-25 |
Class II
|
Ongoing |
Z-2268-2025 |
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456 |
— |
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-mot… |
| 2025-06-25 |
Class II
|
Ongoing |
Z-2267-2025 |
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457 |
— |
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-mot… |
| 2025-06-25 |
Class II
|
Ongoing |
Z-2266-2025 |
UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100 |
— |
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-mot… |
| 2025-06-25 |
Class II
|
Ongoing |
Z-1772-2026 |
MicroScan Neg MIC 3J REF C54814 |
— |
Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics |
| 2025-06-12 |
Class II
|
Ongoing |
Z-2152-2025 |
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and pl… |
— |
A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity… |
| 2025-05-07 |
Class II
|
Ongoing |
Z-1996-2025 |
DxI 9000 Access Immunoassay Analyzer C11137 |
— |
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and de… |
| 2025-05-05 |
Class II
|
Ongoing |
Z-1901-2025 |
Access Testosterone assay, Catalog Number 33560 |
— |
Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosteron… |
| 2025-04-23 |
Class II
|
Ongoing |
Z-1926-2025 |
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20 |
— |
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introd… |
| 2025-04-23 |
Class II
|
Ongoing |
Z-1913-2025 |
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20 |
— |
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being genera… |
| 2025-04-08 |
Class II
|
Ongoing |
Z-2028-2025 |
REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C4… |
— |
Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is … |
| 2025-03-27 |
Class II
|
Ongoing |
Z-1664-2025 |
Beckman Coulter DxI 9000 Access Immunoassay Analyzer |
— |
When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test… |
| 2025-03-20 |
Class II
|
Ongoing |
Z-1784-2025 |
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. … |
— |
Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested calibration order … |
| 2025-03-17 |
Class II
|
Ongoing |
Z-1672-2025 |
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 … |
— |
The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results. |
| 2025-02-27 |
Class II
|
Completed |
Z-2115-2025 |
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850 |
— |
Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause e… |
| 2025-02-26 |
Class II
|
Ongoing |
Z-1517-2025 |
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 … |
— |
Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a cal… |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1387-2025 |
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278 |
— |
Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 c… |
| 2025-02-05 |
Class II
|
Ongoing |
Z-1388-2025 |
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137. |
— |
the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk… |
| 2025-02-05 |
Class II
|
Ongoing |
Z-1386-2025 |
Access 2 Immunoassay Analyzer, Catalog Number 81600N |
— |
Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase p… |
| 2025-02-03 |
Class II
|
Ongoing |
Z-1249-2025 |
Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney,… |
— |
Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the aff… |
| 2025-01-02 |
Class II
|
Ongoing |
Z-1112-2025 |
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems |
— |
Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. … |
| 2024-11-26 |
Class II
|
Ongoing |
Z-0803-2025 |
Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of int… |
— |
Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could… |
| 2024-11-18 |
Class II
|
Ongoing |
Z-0727-2025 |
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac t… |
— |
Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for the recall is: high troponin antigen (>55,000 pg/mL)… |
| 2024-11-13 |
Class II
|
Ongoing |
Z-1326-2025 |
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137 |
— |
The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may genera… |
| 2024-11-08 |
Class II
|
Ongoing |
Z-0673-2025 |
Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determi… |
— |
The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolong… |
| 2024-09-30 |
Class II
|
Ongoing |
Z-0313-2025 |
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination o… |
— |
The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rat… |
| 2024-09-05 |
Class II
|
Ongoing |
Z-0265-2025 |
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The … |
— |
IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results. |
| 2024-08-28 |
Class II
|
Ongoing |
Z-0094-2025 |
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdinatio… |
— |
Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results. |
| 2024-07-31 |
Class II
|
Ongoing |
Z-0118-2025 |
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMM… |
— |
Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU |
| 2024-07-16 |
Class III
|
Ongoing |
Z-0093-2025 |
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic… |
— |
Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive… |
| 2024-07-12 |
Class II
|
Ongoing |
Z-1529-2025 |
DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, se… |
— |
Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipmen… |
| 2024-07-10 |
Class II
|
Ongoing |
Z-3180-2024 |
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137;… |
— |
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks, compr… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2545-2024 |
Discrete photometric chemistry analyzer for clinical use. |
— |
Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System Analyzers that appear to be caused by misaligned in… |
| 2024-06-04 |
Class II
|
Ongoing |
Z-2414-2024 |
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137. |
— |
The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leadi… |
| 2024-05-27 |
Class II
|
Ongoing |
Z-2428-2024 |
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2 |
— |
LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as … |
| 2024-05-22 |
Class II
|
Ongoing |
Z-2735-2024 |
DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. |
— |
When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and bel… |
| 2024-05-22 |
Class II
|
Ongoing |
Z-2544-2024 |
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. |
— |
The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LA… |
| 2024-04-18 |
Class II
|
Ongoing |
Z-2264-2024 |
DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic |
— |
Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualita… |
| 2024-04-18 |
Class II
|
Ongoing |
Z-0025-2025 |
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitati… |
— |
When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the inst… |
| 2024-03-05 |
Class II
|
Ongoing |
Z-1546-2024 |
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, … |
— |
Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supp… |
| 2024-02-29 |
Class II
|
Ongoing |
Z-2237-2024 |
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It … |
— |
The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cab… |
| 2024-02-08 |
Class II
|
Ongoing |
Z-1303-2024 |
Access Total T4, REF 33800, IVD, thyroxine reagent assay. |
— |
Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results. |
| 2024-02-07 |
Class II
|
Ongoing |
Z-1376-2024 |
Access Substrate, REF 81906, For use with the Access Immunoassay Systems |
— |
On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lots: 234600, 337984, 338040, 338214, 338229, 338289… |
| 2024-01-03 |
Class II
|
Completed |
Z-1115-2025 |
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument |
— |
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results. |
| 2023-12-19 |
Class II
|
Ongoing |
Z-0787-2024 |
iQ Waste Well Adapter, Part Number: 700-3393 |
— |
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has… |
| 2023-12-19 |
Class II
|
Ongoing |
Z-0786-2024 |
REV 2 Flowcell Capsule Spare, Part Number: C04154 |
— |
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has… |
| 2023-12-19 |
Class II
|
Ongoing |
Z-0785-2024 |
iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) … |
— |
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has… |
| 2023-12-19 |
Class II
|
Ongoing |
Z-0784-2024 |
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947 |
— |
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has… |
| 2023-11-21 |
Class II
|
Ongoing |
Z-0982-2024 |
DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior, |
— |
There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI uni… |
| 2023-11-21 |
Class II
|
Ongoing |
Z-0981-2024 |
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410 |
— |
There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definitio… |
| 2023-09-12 |
Class II
|
Ongoing |
Z-0107-2024 |
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic |
— |
The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignore… |
| 2023-07-12 |
Class II
|
Ongoing |
Z-2488-2023 |
Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2 |
— |
Lipemic interference failed to meet the performance specification listed within the IFU. |
| 2023-07-06 |
Class II
|
Ongoing |
Z-0100-2024 |
Access Thyroglobulin Calibrators |
— |
It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distribute… |
| 2023-06-20 |
Class II
|
Ongoing |
Z-2237-2023 |
Ringed DxI Reaction Vessels (RVs) |
— |
Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay System (600, 800 series). The reason for the recall is th… |
| 2023-05-31 |
Class II
|
Ongoing |
Z-2138-2023 |
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells |
— |
Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications. |
| 2023-05-17 |
Class II
|
Ongoing |
Z-2043-2023 |
Access Hybritech p2PSA reagent, REF B03704 and REF A49752. |
— |
Reagent lot numbers include an insufficient concentration of blocking reagent. |
| 2023-04-05 |
Class II
|
Ongoing |
Z-1608-2023 |
Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL |
— |
There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures. |
| 2023-04-05 |
Class II
|
Ongoing |
Z-1607-2023 |
Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL |
— |
There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures. |
| 2023-04-05 |
Class II
|
Ongoing |
Z-1606-2023 |
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL |
— |
There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures. |
| 2023-04-05 |
Class II
|
Ongoing |
Z-1599-2023 |
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis |
— |
Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryov… |
| 2023-04-05 |
Class II
|
Ongoing |
Z-1598-2023 |
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis |
— |
Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryov… |
| 2023-04-05 |
Class II
|
Ongoing |
Z-1597-2023 |
DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis |
— |
Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryov… |
| 2023-04-05 |
Class II
|
Ongoing |
Z-1596-2023 |
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbe… |
— |
Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had Sperm was enabled but not displayed so that a carryov… |
| 2023-03-15 |
Class II
|
Ongoing |
Z-1419-2023 |
Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs. |
— |
The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not correlate with the results of other thyroid markers n… |
| 2023-01-26 |
Class II
|
Ongoing |
Z-1257-2023 |
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbishe… |
— |
An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of complaints from consignees regarding wash arm moti… |
| 2022-11-18 |
Class II
|
Ongoing |
Z-0777-2023 |
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only. |
— |
Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in… |
| 2022-10-03 |
Class II
|
Ongoing |
Z-0269-2023 |
MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280 |
— |
Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate. |
| 2022-02-16 |
Class III
|
Ongoing |
Z-0984-2022 |
Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Contro… |
— |
IRISpec CA failures for glucose. |
| 2021-12-08 |
Class II
|
Terminated |
Z-0692-2022 |
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850 |
— |
Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to… |
| 2021-11-10 |
Class II
|
Ongoing |
Z-0399-2022 |
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825 |
— |
Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed… |
| 2021-08-09 |
Class II
|
Ongoing |
Z-0032-2022 |
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK |
— |
Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The … |
| 2021-08-05 |
Class II
|
Terminated |
Z-2508-2021 |
Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1… |
— |
Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute |
| 2021-07-28 |
Class II
|
Ongoing |
Z-0117-2022 |
Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116 |
— |
Missing splash guard which may expose users to hazardous materials. . |
| 2021-07-21 |
Class II
|
Terminated |
Z-2602-2021 |
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UD… |
— |
There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport samples to the outer lane which does not contain a… |
| 2021-07-15 |
Class II
|
Terminated |
Z-2332-2021 |
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces betwe… |
— |
There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result. |
| 2021-07-01 |
Class II
|
Terminated |
Z-2258-2021 |
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743… |
— |
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . |
| 2021-07-01 |
Class II
|
Terminated |
Z-2257-2021 |
ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI:… |
— |
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . |
| 2021-07-01 |
Class II
|
Terminated |
Z-2256-2021 |
Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01… |
— |
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . |
| 2021-07-01 |
Class II
|
Terminated |
Z-2255-2021 |
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713; |
— |
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . |
| 2021-06-23 |
Class II
|
Ongoing |
Z-2241-2021 |
Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C1… |
— |
Software anomalies that may lead to the generation of erroneous results. |
| 2021-05-07 |
Class II
|
Terminated |
Z-1906-2021 |
Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751 |
— |
SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file … |
| 2021-05-07 |
Class II
|
Terminated |
Z-1905-2021 |
Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744 |
— |
SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file … |
| 2021-04-14 |
Class II
|
Terminated |
Z-1670-2021 |
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.1… |
— |
specimens collected in transport media may result is false negative results when stored in certain conditions. |
| 2020-12-30 |
Class II
|
Terminated |
Z-0875-2021 |
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only… |
— |
The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC. |
| 2020-12-02 |
Class II
|
Terminated |
Z-0720-2021 |
MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or iden… |
— |
Due to a customer report and internal investigation, it was confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Faecali… |
| 2020-08-26 |
Class II
|
Terminated |
Z-3006-2020 |
BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570. |
— |
Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results. |
| 2020-08-18 |
Class II
|
Terminated |
Z-3028-2020 |
UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage:… |
— |
The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end o… |
| 2020-03-30 |
Class II
|
Terminated |
Z-1945-2020 |
iQ200 Series Urine Microscopy Analyzer- All part numbers |
— |
A defect in the SATA power adapter cable within the instrument s computer has the potential risk for an electrical short that may lead to the following outcomes… |
| 2020-03-30 |
Class II
|
Terminated |
Z-1944-2020 |
iChem¿VELOCITY Urine Chemistry System- |
— |
A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following outcomes:… |
| 2020-02-17 |
Class II
|
Terminated |
Z-1535-2020 |
iChemVELOCITY Strips, Catalog 800-7212 |
— |
The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips. |
| 2020-01-29 |
Class II
|
Terminated |
Z-2136-2020 |
ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quanti… |
— |
Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human serum or plasma for diagnosis and treatment of potentially serious… |
| 2020-01-17 |
Class II
|
Terminated |
Z-1673-2020 |
LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Win… |
— |
A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7 operation system. Shortly after the releases some cus… |