Ortho-Clinical Diagnostics
Rochester, NY
This page shows every FDA and USDA recall linked to Ortho-Clinical Diagnostics. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
249
Total Recalls
2002
First Recall
2024
Most Recent
VITROS Performance Verifier II
Mar 22, 2024
· Device
Active
VITROS Performance Verifier I
Mar 22, 2024
· Device
Active
VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only.
VITROS Chemistry Products Calibrator...
Jul 11, 2023
· Device
Active
VITROS XT7600 Integrated System, Product code 6844461
Jul 20, 2020
· Device
Terminated
VITROS XT3400 Chemistry System, Product code 6844458
Jul 20, 2020
· Device
Terminated
VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Prod...
Jul 17, 2020
· Device
Terminated
VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - P...
Jul 17, 2020
· Device
Terminated
VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides qu...
Jul 13, 2020
· Device
Terminated
VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS
In vitro Diagnostic quantitatively measure total bilir...
Jul 13, 2020
· Device
Terminated
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL t...
Jul 13, 2020
· Device
Terminated
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below
Product Code: 6802915 Uniqu...
May 20, 2020
· Device
Terminated
VITROS 5600 Integrated System Software Versions 3.3.3 and below
Product Code: 6802413 Unique Identifier:...
May 20, 2020
· Device
Terminated
VITROS 3600 Immunodiagnostic System - Refurbished
Product Code: 6802914 Unique Identifier: 10758750007103
May 20, 2020
· Device
Terminated
VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below
Product Code: 6802783, Unique Identifie...
May 20, 2020
· Device
Terminated
VITROS XT 7600 Integrated System Software Versions 3.5.1
and below
Product Code:6844461 Unique Identif...
May 20, 2020
· Device
Terminated
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008...
May 11, 2020
· Device
Terminated
VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage:...
May 11, 2020
· Device
Terminated
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 107587500043...
May 11, 2020
· Device
Terminated
VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: F...
May 11, 2020
· Device
Terminated
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750...
Apr 1, 2020
· Device
Terminated
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 107587...
Apr 1, 2020
· Device
Terminated
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Mar 10, 2020
· Device
Terminated
VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides whic...
Sep 10, 2019
· Device
Terminated
VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-l...
Sep 10, 2019
· Device
Terminated
VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contai...
Sep 10, 2019
· Device
Terminated
VITROS 250 Chemistry System, clinical chemistry analyzer
Jul 8, 2019
· Device
Terminated
VITROS 250 Chemistry System, clinical chemistry analyzer
Jul 8, 2019
· Device
Terminated
VITROS 5600 Integrated System, clinical chemistry analyzer
Jul 8, 2019
· Device
Terminated
VITROS 4600 Chemistry System, clinical chemistry analyzer
Jul 8, 2019
· Device
Terminated
VITROS 250AT Chemistry System, clinical chemistry analyzer
Jul 8, 2019
· Device
Terminated
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Jul 8, 2019
· Device
Terminated
VITROS 4600 Chemistry System, clinical chemistry analyzer
Jul 8, 2019
· Device
Terminated
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Jul 8, 2019
· Device
Terminated
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Jul 8, 2019
· Device
Terminated
VITROS 5600 Integrated System, clinical chemistry analyzer
Jul 8, 2019
· Device
Terminated
VITROS 350 Chemistry System, clinical chemistry analyzer
Jul 8, 2019
· Device
Terminated
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Jul 8, 2019
· Device
Terminated
VITROS Chemistry Products GLU Slides-Product Code:1707801.
IVD VITROS Chemistry Products GLU Slides quantitat...
Jun 17, 2019
· Device
Terminated
VITROS 350 Chemistry System, Product Code
6802153, (UDI # 10758750002054)
Product Usage:
Performs discrete c...
Apr 8, 2019
· Device
Terminated
VITROS 250 Chemistry System Refurbished, Product Code 6801759,
(UDI # 10758750001330)
Product Usage:
Performs...
Apr 8, 2019
· Device
Terminated
VITROS 250 Chemistry System, Product Code 8132086,
(UDI # 10758750004409)
Product Usage:
Performs discrete c...
Apr 8, 2019
· Device
Terminated
VITROS 250AT Chemistry System, Product Code 1758143,
(UDI # 10758750000036)
Product Usage:
Performs discrete...
Apr 8, 2019
· Device
Terminated
VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW
Product Code: 6844461
Product Usage:
INTENDED USE: Fo...
Mar 20, 2019
· Device
Terminated
VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658
Product Usage:
The VITROS XT 7600 I...
Mar 11, 2019
· Device
Terminated
VITROS 5600 Integrated System -Software V3.3.2 & below
Product Code: 6802413
For use in the in vitro quan...
Feb 20, 2019
· Device
Terminated
VITROS 3600 Immunoassay System Refurbished-Software V3.3.2 & below
Product Code: 6802914
For use in the in v...
Feb 20, 2019
· Device
Terminated
VITROS ECi Immunodiagnostic System Refurbished
Product Code: 6801059
For use in the in vitro quantitative, s...
Feb 20, 2019
· Device
Terminated
VITROS 5600 Integrated System Refurbished-Software V3.3.2 & below
Product Code: 6802915
For use in the in...
Feb 20, 2019
· Device
Terminated
VITROS ECi/ECiQ Immunodiagnostic System
Product Code: 1922814
For use in the in vitro quantitative, semi-qu...
Feb 20, 2019
· Device
Terminated
VITROS XT 7600 Integrated System-Software V3.4.1 & below
Product Code: 6844461
For use in the in vitro quan...
Feb 20, 2019
· Device
Terminated