FDA recall record · openFDA
Ortho-Clinical Diagnostics, Inc.
55 FDA recalls on record (2023–2025) — 55 device. 55 still ongoing.
0
Class I (most serious)
52
Class II
3
Class III
55
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues rela 5
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not u 5
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable West 5
Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase 4
MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integ 3
Recalls
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 9 Class II 2025-04-14 VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package c Class II 2025-06-12 Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; S Class II 2025-05-09 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Num Class II 2025-06-10 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Nu Class II 2025-06-10 VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a Class II 2025-07-29 Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Class II 2025-03-24 VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides); Class II 2025-06-10 Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total o Class II 2025-07-29 VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261; Class II 2025-07-09 Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Class II 2025-05-09 VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides); Class II 2025-06-10 Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915 Class II 2025-05-09 VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished) Class II 2024-01-26 VITROS XT 7600 Integrated System, Catalog No. 6844461 Class II 2024-01-26 VITROS 5600 Integrated System (New and Refurbished) Class II 2024-01-22 Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certif Class II 2024-12-19 Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified Class II 2024-12-19 Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Cer Class II 2024-12-19 VITROS XT7600 Integrated System Class II 2024-01-22 VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 Class II 2024-07-03 VITROS XT 3400 Chemistry System, Catalog No. 6844458 Class II 2024-01-26 VITROS 3600 Immunodiagnostic System (New and Refurbished) Class II 2024-01-22 VITROS XT 7600 Integrated System, Catalog No. 6844461 Class II 2024-01-26 VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished) Class II 2024-01-26 The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein Class II 2024-07-10 VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished) Class II 2024-01-26 VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration Class II 2024-10-11 VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished) Class II 2024-01-26 VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished) Class II 2024-01-26 VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Produ Class II 2024-05-21 VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibra Class II 2024-03-01 VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished) Class II 2024-01-26 VITROS XT 3400 Chemistry System, Catalog No. 6844458 Class II 2024-01-26 VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0 Class II 2023-10-10 VITROS XT Chemistry Products ALKP Slides Class II 2023-08-05 VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Prod Class II 2023-11-27 VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a Class II 2023-03-10 QMS Tacrolimus Calibrators, Product code 10015573 Class II 2023-11-21 VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains Class II 2023-09-12 VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0 Class II 2023-10-10 VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement Class II 2023-03-10 VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative Class II 2023-03-10 VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c ( Class II 2023-04-17 VITROS XT Chemistry Products TBIL-ALKP Slides Class II 2023-08-05 VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0 Class II 2023-10-10 VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Dat Class II 2023-04-14 VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD Class II 2023-03-09 VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0 Class II 2023-10-10 Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Che Class II 2023-08-09 VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3 Class II 2023-10-10 VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitat Class II 2023-10-25 VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the Class III 2024-05-14 VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calib Class III 2024-05-08 VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the Class III 2023-05-18
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.