| 2025-07-29 |
Class II
|
Ongoing |
Z-2560-2025 |
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a … |
— |
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lot… |
| 2025-07-29 |
Class II
|
Ongoing |
Z-2559-2025 |
Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total o… |
— |
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lot… |
| 2025-07-09 |
Class II
|
Ongoing |
Z-2335-2025 |
VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261; |
— |
Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS … |
| 2025-06-12 |
Class II
|
Ongoing |
Z-2073-2025 |
VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package c… |
— |
Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable t… |
| 2025-06-10 |
Class II
|
Ongoing |
Z-2123-2025 |
VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides); |
— |
Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs … |
| 2025-06-10 |
Class II
|
Ongoing |
Z-2122-2025 |
VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides); |
— |
Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs … |
| 2025-06-10 |
Class II
|
Ongoing |
Z-2121-2025 |
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Nu… |
— |
Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs … |
| 2025-06-10 |
Class II
|
Ongoing |
Z-2120-2025 |
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Num… |
— |
Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs … |
| 2025-05-09 |
Class II
|
Ongoing |
Z-2040-2025 |
Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software… |
— |
a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expire… |
| 2025-05-09 |
Class II
|
Ongoing |
Z-2039-2025 |
Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; S… |
— |
a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expire… |
| 2025-05-09 |
Class II
|
Ongoing |
Z-2038-2025 |
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915 |
— |
A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expire… |
| 2025-04-14 |
Class II
|
Ongoing |
Z-1876-2025 |
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 9… |
— |
Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label. |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1948-2025 |
Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software… |
— |
It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (onl… |
| 2024-12-19 |
Class II
|
Ongoing |
Z-1007-2025 |
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Cer… |
— |
The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life… |
| 2024-12-19 |
Class II
|
Ongoing |
Z-1006-2025 |
Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certif… |
— |
The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life ex… |
| 2024-12-19 |
Class II
|
Ongoing |
Z-1005-2025 |
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified… |
— |
The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expir… |
| 2024-10-11 |
Class II
|
Ongoing |
Z-0535-2025 |
VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration… |
— |
May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) wh… |
| 2024-07-10 |
Class II
|
Ongoing |
Z-2684-2024 |
The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein… |
— |
The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel through the … |
| 2024-07-03 |
Class II
|
Ongoing |
Z-2580-2024 |
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 |
— |
It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatm… |
| 2024-05-21 |
Class II
|
Ongoing |
Z-2266-2024 |
VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Produ… |
— |
VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemis… |
| 2024-05-14 |
Class III
|
Ongoing |
Z-2245-2024 |
VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the… |
— |
Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its true expirati… |
| 2024-05-08 |
Class III
|
Ongoing |
Z-2019-2024 |
VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calib… |
— |
The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is… |
| 2024-03-01 |
Class II
|
Ongoing |
Z-2142-2024 |
VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibra… |
— |
Potential for positively biased results due to signal reduction over shelf life. |
| 2024-02-27 |
Class II
|
Ongoing |
Z-1373-2024 |
VITROS Performance Verifier II |
— |
The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Qua… |
| 2024-02-27 |
Class II
|
Ongoing |
Z-1372-2024 |
VITROS Performance Verifier I |
— |
The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Qua… |
| 2024-01-26 |
Class II
|
Ongoing |
Z-1233-2024 |
VITROS XT 7600 Integrated System, Catalog No. 6844461 |
— |
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. W… |
| 2024-01-26 |
Class II
|
Ongoing |
Z-1232-2024 |
VITROS XT 3400 Chemistry System, Catalog No. 6844458 |
— |
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. W… |
| 2024-01-26 |
Class II
|
Ongoing |
Z-1231-2024 |
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished) |
— |
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. W… |
| 2024-01-26 |
Class II
|
Ongoing |
Z-1230-2024 |
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished) |
— |
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. W… |
| 2024-01-26 |
Class II
|
Ongoing |
Z-1229-2024 |
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished) |
— |
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. W… |
| 2024-01-26 |
Class II
|
Ongoing |
Z-1228-2024 |
VITROS XT 7600 Integrated System, Catalog No. 6844461 |
— |
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the us… |
| 2024-01-26 |
Class II
|
Ongoing |
Z-1227-2024 |
VITROS XT 3400 Chemistry System, Catalog No. 6844458 |
— |
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the us… |
| 2024-01-26 |
Class II
|
Ongoing |
Z-1226-2024 |
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished) |
— |
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the us… |
| 2024-01-26 |
Class II
|
Ongoing |
Z-1225-2024 |
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished) |
— |
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the us… |
| 2024-01-26 |
Class II
|
Ongoing |
Z-1224-2024 |
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished) |
— |
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the us… |
| 2024-01-22 |
Class II
|
Ongoing |
Z-1222-2024 |
VITROS XT7600 Integrated System |
— |
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 In… |
| 2024-01-22 |
Class II
|
Ongoing |
Z-1221-2024 |
VITROS 5600 Integrated System (New and Refurbished) |
— |
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 In… |
| 2024-01-22 |
Class II
|
Ongoing |
Z-1220-2024 |
VITROS 3600 Immunodiagnostic System (New and Refurbished) |
— |
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 In… |
| 2023-11-27 |
Class II
|
Ongoing |
Z-0772-2024 |
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Prod… |
— |
Affected lots may experience increased calibration failures or an increase in falsely elevated results. |
| 2023-11-21 |
Class II
|
Ongoing |
Z-0712-2024 |
QMS Tacrolimus Calibrators, Product code 10015573 |
— |
Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to de… |
| 2023-10-25 |
Class II
|
Ongoing |
Z-0510-2024 |
VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitat… |
— |
Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of VITROS ECO2 slides included carts which may contai… |
| 2023-10-10 |
Class II
|
Ongoing |
Z-0547-2024 |
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0 |
— |
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unrespo… |
| 2023-10-10 |
Class II
|
Ongoing |
Z-0546-2024 |
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0 |
— |
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unrespo… |
| 2023-10-10 |
Class II
|
Ongoing |
Z-0545-2024 |
VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0 |
— |
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unrespo… |
| 2023-10-10 |
Class II
|
Ongoing |
Z-0544-2024 |
VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0 |
— |
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unrespo… |
| 2023-10-10 |
Class II
|
Ongoing |
Z-0543-2024 |
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3… |
— |
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unrespo… |
| 2023-09-12 |
Class II
|
Ongoing |
Z-0236-2024 |
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains … |
— |
Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the sli… |
| 2023-08-09 |
Class II
|
Ongoing |
Z-0008-2024 |
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Che… |
— |
Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Dat… |
| 2023-08-05 |
Class II
|
Ongoing |
Z-2624-2023 |
VITROS XT Chemistry Products ALKP Slides |
— |
Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not p… |
| 2023-08-05 |
Class II
|
Ongoing |
Z-2623-2023 |
VITROS XT Chemistry Products TBIL-ALKP Slides |
— |
Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not p… |
| 2023-06-05 |
Class II
|
Ongoing |
Z-2358-2023 |
VITROS Immunodiagnostic Products Troponin I ES Calibrators |
— |
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results. |
| 2023-06-05 |
Class II
|
Ongoing |
Z-2357-2023 |
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack |
— |
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results. |
| 2023-05-18 |
Class III
|
Ongoing |
Z-2225-2023 |
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the… |
— |
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU). |
| 2023-05-08 |
Class II
|
Ongoing |
Z-2129-2023 |
VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- … |
— |
Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within th… |
| 2023-04-17 |
Class II
|
Ongoing |
Z-1628-2023 |
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (… |
— |
Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis |
| 2023-04-14 |
Class II
|
Ongoing |
Z-1664-2023 |
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Dat… |
— |
Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing |
| 2023-03-10 |
Class II
|
Ongoing |
Z-1557-2023 |
VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative … |
— |
MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed re… |
| 2023-03-10 |
Class II
|
Ongoing |
Z-1556-2023 |
VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a… |
— |
MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed re… |
| 2023-03-10 |
Class II
|
Ongoing |
Z-1555-2023 |
VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement … |
— |
MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed re… |
| 2023-03-09 |
Class II
|
Ongoing |
Z-1396-2023 |
VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD… |
— |
Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), … |
| 2022-11-17 |
Class II
|
Ongoing |
Z-0878-2023 |
VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid ho… |
— |
Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results |
| 2022-10-13 |
Class II
|
Ongoing |
Z-0220-2023 |
VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product C… |
— |
Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT … |
| 2022-07-19 |
Class II
|
Ongoing |
Z-1676-2022 |
VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461 |
— |
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED u… |
| 2022-07-19 |
Class II
|
Ongoing |
Z-1675-2022 |
VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458 |
— |
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED u… |
| 2022-05-26 |
Class II
|
Ongoing |
Z-1367-2022 |
Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and V… |
— |
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU). |
| 2022-03-25 |
Class II
|
Ongoing |
Z-1114-2022 |
VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793 |
— |
Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecis… |
| 2022-03-25 |
Class II
|
Ongoing |
Z-1113-2022 |
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198 |
— |
Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecis… |
| 2022-03-25 |
Class II
|
Ongoing |
Z-1112-2022 |
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922 |
— |
Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecis… |
| 2021-12-10 |
Class II
|
Ongoing |
Z-0735-2022 |
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box. |
— |
The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and t… |
| 2021-11-22 |
Class II
|
Ongoing |
Z-0503-2022 |
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack |
— |
Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Rea… |
| 2021-10-15 |
Class III
|
Terminated |
Z-0247-2022 |
VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of t… |
— |
Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained inf… |
| 2021-05-03 |
Class II
|
Terminated |
Z-1688-2021 |
VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qu… |
— |
Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-Co… |
| 2021-03-26 |
Class II
|
Terminated |
Z-1489-2021 |
VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the … |
— |
Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer fails to no… |
| 2021-02-18 |
Class II
|
Terminated |
Z-1295-2021 |
VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4… |
— |
Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26… |
| 2021-02-12 |
Class II
|
Terminated |
Z-1267-2021 |
VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used … |
— |
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media |
| 2021-02-12 |
Class II
|
Terminated |
Z-1266-2021 |
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products S… |
— |
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media |
| 2021-01-14 |
Class II
|
Terminated |
Z-1136-2021 |
VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagen… |
— |
A deformity affecting a specific lot of VITROS¿ Chemistry Products VersaTips. Deformed VersaTips results may be biased by up to +/-16% for both immunometric and… |
| 2020-11-20 |
Class II
|
Terminated |
Z-0801-2021 |
VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical… |
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A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample… |
| 2020-11-20 |
Class II
|
Terminated |
Z-0800-2021 |
enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the i… |
— |
A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample… |
| 2020-07-13 |
Class II
|
Terminated |
Z-2875-2020 |
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within… |
— |
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides |
| 2020-07-13 |
Class II
|
Terminated |
Z-2874-2020 |
VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitative… |
— |
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides |
| 2020-07-13 |
Class II
|
Terminated |
Z-2873-2020 |
VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL… |
— |
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides |
| 2020-05-11 |
Class II
|
Terminated |
Z-2367-2020 |
VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vit… |
— |
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on t… |
| 2020-05-11 |
Class II
|
Terminated |
Z-2366-2020 |
VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitr… |
— |
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on t… |
| 2020-05-11 |
Class II
|
Terminated |
Z-2365-2020 |
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Produ… |
— |
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on t… |
| 2020-05-11 |
Class II
|
Terminated |
Z-2364-2020 |
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Prod… |
— |
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on t… |
| 2020-04-01 |
Class II
|
Terminated |
Z-1931-2020 |
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - P… |
— |
The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results. |
| 2020-04-01 |
Class II
|
Terminated |
Z-1930-2020 |
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 -… |
— |
The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results. |