Ortho-Clinical Diagnostics, Inc. recalls

19 recalls on record · latest: July 29, 2025

Official U.S. recall history for Ortho-Clinical Diagnostics, Inc., compiled from official government records.

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Ortho-Clinical Diagnostics, Inc. recalls Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total…

July 29, 2025 · Medical device recalls Moderate risk VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Syste…

Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a…

July 29, 2025 · Medical device recalls Moderate risk VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Syste…

Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;

July 9, 2025 · Medical device recalls Moderate risk Generations 67 and above of VITROS Ca Slides are experiencing an increased occu…

Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package…

June 12, 2025 · Medical device recalls Moderate risk Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may gener…

Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);

June 10, 2025 · Medical device recalls Moderate risk Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are…

Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);

June 10, 2025 · Medical device recalls Moderate risk Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are…

Ortho-Clinical Diagnostics, Inc. recalls Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Num…

June 10, 2025 · Medical device recalls Moderate risk Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are…

Ortho-Clinical Diagnostics, Inc. recalls Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Numb…

June 10, 2025 · Medical device recalls Moderate risk Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are…

Ortho-Clinical Diagnostics, Inc. recalls Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915

May 9, 2025 · Medical device recalls Moderate risk A software anomaly allows test results to be reported using Micro Tip and Micro…

Ortho-Clinical Diagnostics, Inc. recalls Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software V…

May 9, 2025 · Medical device recalls Moderate risk a software anomaly allows test results to be reported using Micro Tip and Micro…

Ortho-Clinical Diagnostics, Inc. recalls Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Sof…

May 9, 2025 · Medical device recalls Moderate risk a software anomaly allows test results to be reported using Micro Tip and Micro…

Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of…

April 14, 2025 · Medical device recalls Moderate risk Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, fo…

Ortho-Clinical Diagnostics, Inc. recalls Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software V…

March 24, 2025 · Medical device recalls Moderate risk It was determined that there could be a false positive rate of up to 16.7% for…

Ortho-Clinical Diagnostics, INc. recalls Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Cert…

December 19, 2024 · Medical device recalls Moderate risk The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correct…

Ortho-Clinical Diagnostics, INc. recalls Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/…

December 19, 2024 · Medical device recalls Moderate risk The VITROS 5600 Integrated System software versions 3.8.0 may not correctly not…

Ortho-Clinical Diagnostics, INc. recalls Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certifi…

December 19, 2024 · Medical device recalls Moderate risk The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly…

Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentratio…

October 11, 2024 · Medical device recalls Moderate risk May Generate Negatively Biased Results When Testing Samples with High Concentra…

Ortho-Clinical Diagnostics, Inc. recalls The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protei…

July 10, 2024 · Medical device recalls Moderate risk The reason for this recall is QuidelOrtho has determined that during normal use…

Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2

July 3, 2024 · Medical device recalls Moderate risk It was confirmed that fibrinogen in patient plasma samples precipitates out of…