Ortho Clinical Diagnostics

Complete recall history across all FDA and CPSC categories — 22 total recalls

Ortho Clinical Diagnostics 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 (22)

FDA medical device enforcement actions by Ortho Clinical Diagnostics

Date Product Reason Class
Jul 20, 2020 VITROS XT3400 Chemistry System, Product code 6844458 When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may ... Class II
Jul 20, 2020 VITROS XT7600 Integrated System, Product code 6844461 When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may ... Class II
Jul 17, 2020 VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6... The reagent bottles may be swapped within the reagent pack, which may lead to... Class II
Jul 17, 2020 VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog numbe... The reagent bottles may be swapped within the reagent pack, which may lead to... Class II
May 20, 2020 VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Un... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be ... Class II
May 20, 2020 VITROS 5600 Integrated System Software Versions 3.3.3 and below Product C... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be ... Class II
May 20, 2020 VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Produ... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be ... Class II
May 20, 2020 VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be ... Class II
May 20, 2020 VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Produc... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be ... Class II
Mar 10, 2020 VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468 The specified reagent packs exhibit an increase in the frequency of unsuccess... Class III
Jul 8, 2019 VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical che... Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II
Jul 8, 2019 VITROS 5600 Integrated System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II
Jul 8, 2019 VITROS 350 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II
Jul 8, 2019 VITROS 4600 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II
Jul 8, 2019 VITROS 4600 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II
Jul 8, 2019 VITROS 250AT Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II
Jul 8, 2019 VITROS 5,1 FS Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II
Jul 8, 2019 VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical che... Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II
Jul 8, 2019 VITROS 5,1 FS Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II
Jul 8, 2019 VITROS 250 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II
Jul 8, 2019 VITROS 250 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II
Jul 8, 2019 VITROS 5600 Integrated System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II

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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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