Ortho Clinical Diagnostics Inc

Complete recall history across all FDA and CPSC categories — 16 total recalls

Ortho Clinical Diagnostics Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (16)

FDA medical device enforcement actions by Ortho Clinical Diagnostics Inc

Date Product Reason Class
Sep 10, 2021 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (I... VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Ou... Class II
Dec 15, 2020 VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentra... Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS ... Class II
Dec 15, 2020 VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quanti... Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS ... Class II
Dec 11, 2020 VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide car... VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results ... Class II
Oct 16, 2020 VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use... Product instability; biased ALKP values obtained from VITROS Chemistry Produc... Class III
Sep 30, 2020 VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: I... Elevated sample results signal/cutoff (s/c) values when using eight (8) lots ... Class II
Sep 30, 2020 VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage... Elevated sample results signal/cutoff (s/c) values when using eight (8) lots ... Class II
Dec 16, 2019 VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/35... Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITR... Class II
Oct 14, 2019 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used... Potential for the instability of the diluents VITROS 7% BSA (Product Code 826... Class II
Oct 14, 2019 Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dil... Potential for the instability of the diluents VITROS 7% BSA (Product Code 826... Class II
Nov 29, 2018 Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration... A stability issue in the calibrators may cause calibration failures or atypic... Class II
Jul 12, 2018 VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997 The recalling firm determined that biased results may occur for specific VITR... Class II
Jul 12, 2018 VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1... The recalling firm determined that biased results may occur for specific VITR... Class II
Jul 12, 2018 VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922 The recalling firm determined that biased results may occur for specific VITR... Class II
Jul 12, 2018 VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266 The recalling firm determined that biased results may occur for specific VITR... Class II
Jul 10, 2017 VITROS Chemistry Products Performance Verifier is used as an assayed control ... VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stabi... Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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