Ortho-Clinical Diagnostics
151 recalls on record · Latest: Apr 3, 2024
FDA Devices Moderate Apr 3, 2024
VITROS Performance Verifier I
FDA Devices Moderate Apr 3, 2024
VITROS Performance Verifier II
FDA Devices Moderate Aug 16, 2023
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
FDA Devices Moderate Sep 2, 2020
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Prod…
FDA Devices Moderate Sep 2, 2020
VITROS XT7600 Integrated System, Product code 6844461
FDA Devices Moderate Sep 2, 2020
VITROS XT3400 Chemistry System, Product code 6844458
FDA Devices Moderate Sep 2, 2020
VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and …
FDA Devices Moderate Aug 19, 2020
VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro dia…
FDA Devices Moderate Jul 8, 2020
VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
FDA Devices Moderate Jul 8, 2020
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
FDA Devices Moderate Jul 8, 2020
VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
FDA Devices Moderate Jun 24, 2020
VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quan…
FDA Devices Moderate May 20, 2020
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chem…
FDA Devices Moderate May 20, 2020
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Ch…
FDA Devices Low May 6, 2020
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
FDA Devices Moderate Nov 13, 2019
VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-laye…
FDA Devices Moderate Nov 13, 2019
VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
FDA Devices Moderate Nov 13, 2019
VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
FDA Devices Moderate Aug 14, 2019
VITROS 5600 Integrated System, clinical chemistry analyzer
FDA Devices Moderate Aug 14, 2019
VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentra…
FDA Devices Moderate Aug 14, 2019
VITROS 250 Chemistry System, clinical chemistry analyzer
FDA Devices Moderate Aug 14, 2019
VITROS 250 Chemistry System, clinical chemistry analyzer
FDA Devices Moderate Aug 14, 2019
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
FDA Devices Moderate Aug 14, 2019
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
FDA Devices Moderate Aug 14, 2019
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
FDA Devices Moderate Aug 14, 2019
VITROS 250AT Chemistry System, clinical chemistry analyzer
FDA Devices Moderate Aug 14, 2019
VITROS 4600 Chemistry System, clinical chemistry analyzer
FDA Devices Moderate Jul 10, 2019
VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and …
FDA Devices Moderate Jul 10, 2019
VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and …
FDA Devices Moderate Jul 10, 2019
VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete clinical tests on serum, …
FDA Devices Moderate May 15, 2019
VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and quali…
FDA Devices Moderate May 15, 2019
VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative measure…
FDA Devices Moderate May 15, 2019
VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qu…
FDA Devices Moderate May 15, 2019
VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, semi-quantitati…
FDA Devices Moderate May 15, 2019
VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qualitative me…
FDA Devices Moderate May 15, 2019
VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantitative, and qu…
FDA Devices Moderate May 1, 2019
VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use…
FDA Devices Moderate Mar 20, 2019
VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na…
FDA Devices Moderate Jan 9, 2019
VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Bra…
FDA Devices Moderate Dec 26, 2018
VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interes…
FDA Devices Moderate Dec 26, 2018
VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical…
FDA Devices Moderate Nov 14, 2018
VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measur…
FDA Devices Moderate Oct 10, 2018
VITROS Sodium Slides, Catalog # 837 9034
FDA Devices Low Sep 26, 2018
VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic…
FDA Devices Low Sep 19, 2018
VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides…
FDA Devices Low Sep 19, 2018
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides q…
FDA Devices Moderate Mar 14, 2018
VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic
FDA Devices Moderate Mar 14, 2018
VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
FDA Devices Moderate Dec 20, 2017
enGen Track System with TCAutomation Software Version 4.2
FDA Devices Moderate Apr 19, 2017