Brand

Ortho-clinical Diagnostics Recalls

142 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Ortho-clinical Diagnostics.

142Total Recalls
0Critical
16.1MUnits Affected
Feb 27, 2024Most Recent
All Recalls

Every Ortho-clinical Diagnostics Recall

Sorted by most recent. Click any recall for full details.

142 recalls
High RiskFDA
Ortho-clinical Diagnostics
VITROS Performance Verifier I
Medical Devices·10,911 affected·Feb 27, 2024
High RiskFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Diagnostic Devices·4,013 affected·Jun 5, 2023
High RiskFDA
Ortho Clinical Diagnostics
VITROS XT7600 Integrated System, Product code 6844461
Medical Devices·0 affected·Jul 20, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS XT3400 Chemistry System, Product code 6844458
Medical Devices·0 affected·Jul 20, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For ...
Diagnostic Devices·2,349 affected·Jul 17, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Ch...
Diagnostic Devices·4,076 affected·Jul 13, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration i...
Diagnostic Devices·149,370 affected·Jul 13, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
Diagnostic Devices·779 affected·May 20, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
Medical Devices·130 affected·May 20, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
Medical Devices·353 affected·May 20, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use ...
Diagnostic Devices·0 affected·May 11, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The...
Medical Devices·0 affected·Apr 1, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: T...
Medical Devices·0 affected·Apr 1, 2020
RecallFDA
Ortho Clinical Diagnostics
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Diagnostic Devices·3,181 affected·Mar 10, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry...
Diagnostic Devices·1,365,545 affected·Sep 10, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
Diagnostic Devices·1,365,545 affected·Sep 10, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-...
Diagnostic Devices·1,365,545 affected·Sep 10, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS 5600 Integrated System, clinical chemistry analyzer
Medical Devices·2,531 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS 250 Chemistry System, clinical chemistry analyzer
Medical Devices·2 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS 250 Chemistry System, clinical chemistry analyzer
Medical Devices·30 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Medical Devices·55 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Medical Devices·0 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Medical Devices·1,051 affected·Jul 8, 2019
High RiskFDA
Ortho Clinical Diagnostics
VITROS 250AT Chemistry System, clinical chemistry analyzer
Medical Devices·30 affected·Jul 8, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GL...
Diabetes Devices·1,099 affected·Jun 17, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum,...
Medical Devices·3,889 affected·Apr 8, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum,...
Medical Devices·5,020 affected·Apr 8, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete clinical test...
Medical Devices·2,411 affected·Apr 8, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is inte...
Diagnostic Devices·80 affected·Mar 11, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitativ...
Diagnostic Devices·267 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualita...
Diagnostic Devices·45 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantita...
Diagnostic Devices·55 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, sem...
Diagnostic Devices·4 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qu...
Diagnostic Devices·25 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantita...
Diagnostic Devices·62 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measur...
Diagnostic Devices·1,448 affected·Jan 22, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-term...
Cardiac Devices·46,598 affected·Nov 1, 2018
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clin...
Medical Devices·1,105 affected·Oct 19, 2018
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes...
Diagnostic Devices·682 affected·Oct 19, 2018
High RiskFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantit...
Diagnostic Devices·6,630 affected·Aug 28, 2018
Medium RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Product...
Diagnostic Devices·128,196 affected·Jul 11, 2018
Medium RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitr...
Diagnostic Devices·627,543 affected·Jul 11, 2018
Medium RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products ...
Diagnostic Devices·420,105 affected·Jul 11, 2018
High RiskFDA
Ortho-clinical Diagnostics
VITROS Sodium Slides, Catalog # 837 9034
Medical Devices·0 affected·May 5, 2018
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic
Diagnostic Devices·196 affected·Sep 22, 2017
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
Diagnostic Devices·102 affected·Sep 22, 2017
High RiskFDA
Ortho-clinical Diagnostics
enGen Track System with TCAutomation Software Version 4.2
Medical Devices·16 affected·Apr 26, 2017
High RiskFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35...
Diagnostic Devices·6,324 affected·Mar 7, 2017