Ortho Clinical Diagnostics recalls

Ortho Clinical Diagnostics appears in 311 official U.S. recall notices indexed by RecallRadar, most recently on 2025-09-24.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Chemistry Products LAC Slides
  FDA Device · Class II · 2025-09-24 · Ortho Clinical Diagnostics
• VITROS Chemistry Products LAC Slides
  FDA Device · Class II · 2025-09-24 · Ortho Clinical Diagnostics
• VITROS Chemistry Products Ca Slides
  FDA Device · Class II · 2025-08-27 · Ortho Clinical Diagnostics
• VITROS Chemistry Products CHE Slides
  FDA Device · Class II · 2025-07-23 · Ortho Clinical Diagnostics
• Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Softwar…
  FDA Device · Class II · 2025-07-23 · Ortho Clinical Diagnostics
• VITROS Chemistry Products CHE Slides (Japan)
  FDA Device · Class II · 2025-07-23 · Ortho Clinical Diagnostics
• Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Softwar…
  FDA Device · Class II · 2025-07-23 · Ortho Clinical Diagnostics
• VITROS Chemistry Products OP Reagent Gen 15
  FDA Device · Class II · 2025-07-09 · Ortho Clinical Diagnostics
• Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2…
  FDA Device · Class II · 2025-07-09 · Ortho Clinical Diagnostics
• Brand Name: VITROS
  FDA Device · Class II · 2025-07-09 · Ortho Clinical Diagnostics
• Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
  FDA Device · Class II · 2025-07-09 · Ortho Clinical Diagnostics
• Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicab…
  FDA Device · Class II · 2025-06-18 · Ortho Clinical Diagnostics
• VITROS Chemistry Products CRP Slides
  FDA Device · Class II · 2025-06-04 · Ortho Clinical Diagnostics
• Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished),…
  FDA Device · Class II · 2025-01-29 · Ortho Clinical Diagnostics
• Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 690400…
  FDA Device · Class II · 2025-01-29 · Ortho Clinical Diagnostics
• Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China)…
  FDA Device · Class II · 2025-01-29 · Ortho Clinical Diagnostics
• VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasm…
  FDA Device · Class II · 2024-12-04 · Ortho Clinical Diagnostics
• The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side…
  FDA Device · Class II · 2024-08-28 · Ortho Clinical Diagnostics
• VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
  FDA Device · Class II · 2024-08-21 · Ortho Clinical Diagnostics
• VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754
  FDA Device · Class II · 2024-07-10 · Ortho Clinical Diagnostics
• VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 760…
  FDA Device · Class III · 2024-07-10 · Ortho Clinical Diagnostics
• VITROS Immunodiagnostic Products Anti HBs Calibrators
  FDA Device · Class II · 2024-06-19 · Ortho Clinical Diagnostics
• VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly
  FDA Device · Class III · 2024-06-12 · Ortho Clinical Diagnostics
• VITROS Performance Verifier II
  FDA Device · Class II · 2024-04-03 · Ortho Clinical Diagnostics
• VITROS Performance Verifier I
  FDA Device · Class II · 2024-04-03 · Ortho Clinical Diagnostics
• VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• VITROS 5600 Integrated System (New and Refurbished)
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• VITROS 3600 Immunodiagnostic System (New and Refurbished)
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• VITROS XT 3400 Chemistry System, Catalog No. 6844458
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• VITROS XT 7600 Integrated System, Catalog No. 6844461
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• VITROS XT 3400 Chemistry System, Catalog No. 6844458
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• VITROS XT 7600 Integrated System, Catalog No. 6844461
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• VITROS XT7600 Integrated System
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
  FDA Device · Class II · 2024-03-13 · Ortho Clinical Diagnostics
• VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrat…
  FDA Device · Class II · 2024-01-31 · Ortho Clinical Diagnostics
• QMS Tacrolimus Calibrators, Product code 10015573
  FDA Device · Class II · 2024-01-17 · Ortho Clinical Diagnostics
• VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
  FDA Device · Class II · 2023-12-20 · Ortho Clinical Diagnostics
• VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
  FDA Device · Class II · 2023-12-20 · Ortho Clinical Diagnostics
• VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
  FDA Device · Class II · 2023-12-20 · Ortho Clinical Diagnostics
• VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
  FDA Device · Class II · 2023-12-20 · Ortho Clinical Diagnostics
• VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
  FDA Device · Class II · 2023-12-20 · Ortho Clinical Diagnostics
• VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only
  FDA Device · Class II · 2023-12-13 · Ortho Clinical Diagnostics
• VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartr…
  FDA Device · Class II · 2023-11-15 · Ortho Clinical Diagnostics
• Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refu…
  FDA Device · Class II · 2023-10-11 · Ortho Clinical Diagnostics
• VITROS XT Chemistry Products TBIL-ALKP Slides
  FDA Device · Class II · 2023-09-27 · Ortho Clinical Diagnostics
• VITROS XT Chemistry Products ALKP Slides
  FDA Device · Class II · 2023-09-27 · Ortho Clinical Diagnostics