Ortho-Clinical Diagnostics, Inc.
Rochester, NY
This page shows every FDA and USDA recall linked to Ortho-Clinical Diagnostics, Inc.. 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.
64
Total Recalls
2020
First Recall
2025
Most Recent
Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for...
Sep 12, 2025
· Device
Active
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slid...
Sep 12, 2025
· Device
Active
VITROS Chemistry Products Ca Slides;
Catalog Number: 145 0261;
Aug 15, 2025
· Device
Active
VITROS Chemistry Products CHE Slides;
Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);
Jul 17, 2025
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Active
Brand Name: VITROS Chemistry Products
Product Name: VITROS Chemistry Products Performance Verifier II
Model/Ca...
Jul 17, 2025
· Device
Active
VITROS Chemistry Products CHE Slides (Japan);
Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 sli...
Jul 17, 2025
· Device
Active
Brand Name: VITROS Chemistry Products
Product Name: VITROS Chemistry Products Performance Verifier I
Model/Cat...
Jul 17, 2025
· Device
Active
Brand Name: VITROS
Product Name: VITROS 4600 Chemistry System
Model/Catalog Number: (1) 6802445, (2) 6900440
S...
Jun 27, 2025
· Device
Active
Brand Name: VITROS;
Product Name: VITROS XT 7600 Integrated System;
Model/Catalog Number: (1) 6844461, (2) 627...
Jun 27, 2025
· Device
Active
Brand Name: VITROS
Product Name: VITROS 5600 Integrated System
Model/Catalog Number: (1) 6802413, (2) 6802915
Jun 27, 2025
· Device
Active
Brand Name: Solana Bordetella Complete Assay
Product Name: Solana Bordetella kit
Model/Catalog Number: M308
So...
Jun 11, 2025
· Device
Active
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a...
May 29, 2025
· Device
Active
Brand Name: VITROS
Product Name: VITROS XT 7600 Integrated System
Model/Catalog Number: 6844461 (New), 6272222...
Jan 21, 2025
· Device
Active
Brand Name: VITROS
Product Name: VITROS 3600 Immunodiagnostic System
Model/Catalog Number: 6802783 (New), 6802...
Jan 21, 2025
· Device
Active
Brand Name: VITROS
Product Name: VITROS 5600 Integrated System
Model/Catalog Number: 6802413 (New), 6802415 (C...
Jan 21, 2025
· Device
Active
VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) con...
Nov 25, 2024
· Device
Active
The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a tot...
Aug 16, 2024
· Device
Active
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Aug 12, 2024
· Device
Active
VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labell...
Jun 13, 2024
· Device
Active
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Mar 1, 2024
· Device
Active
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Mar 1, 2024
· Device
Active
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Mar 1, 2024
· Device
Active
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Mar 1, 2024
· Device
Active
VITROS 5600 Integrated System (New and Refurbished)
Mar 1, 2024
· Device
Active
VITROS XT 3400 Chemistry System, Catalog No. 6844458
Mar 1, 2024
· Device
Active
VITROS XT 7600 Integrated System, Catalog No. 6844461
Mar 1, 2024
· Device
Active
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Mar 1, 2024
· Device
Active
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Mar 1, 2024
· Device
Active
VITROS XT7600 Integrated System
Mar 1, 2024
· Device
Active
VITROS XT 3400 Chemistry System, Catalog No. 6844458
Mar 1, 2024
· Device
Active
VITROS 3600 Immunodiagnostic System (New and Refurbished)
Mar 1, 2024
· Device
Active
VITROS XT 7600 Integrated System, Catalog No. 6844461
Mar 1, 2024
· Device
Active
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925
VITROS Immunodiagnos...
Jan 19, 2024
· Device
Active
QMS Tacrolimus Calibrators, Product code 10015573
Jan 11, 2024
· Device
Active
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software...
Dec 13, 2023
· Device
Active
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
Dec 13, 2023
· Device
Active
VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Versio...
Dec 13, 2023
· Device
Active
VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Versi...
Dec 13, 2023
· Device
Active
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Dec 13, 2023
· Device
Active
VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only.
VITROS Chemistry Products ECO2 Slides...
Dec 7, 2023
· Device
Active
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749...
Nov 6, 2023
· Device
Active
VITROS XT Chemistry Products ALKP Slides
Sep 21, 2023
· Device
Active
VITROS XT Chemistry Products TBIL-ALKP Slides
Sep 21, 2023
· Device
Active
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in ver...
Jul 21, 2023
· Device
Active
VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact para...
Jan 4, 2023
· Device
Active