Ortho-Clinical Diagnostics

Complete recall history across all FDA and CPSC categories — 199 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 (199)

FDA medical device enforcement actions by Ortho-Clinical Diagnostics. Showing most recent 50.

Date Product Reason Class
Feb 27, 2024 VITROS Performance Verifier II The issue was mismatched diluent lots assembled into VITRO Chemistry Products... Class II
Feb 27, 2024 VITROS Performance Verifier I The issue was mismatched diluent lots assembled into VITRO Chemistry Products... Class II
Jun 5, 2023 VITROS Immunodiagnostic Products Troponin I ES Calibrators Reagent packs could potentially contain incorrect wells, which will generate ... Class II
Jun 5, 2023 VITROS Immunodiagnostic Products Troponin I ES Reagent Pack Reagent packs could potentially contain incorrect wells, which will generate ... Class II
May 8, 2023 VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VI... Potential to cause biased results in the upper end of the reportable range fo... Class II
Jul 13, 2020 VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS ... Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS Bu... Class II
Jul 13, 2020 VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic q... Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS Bu... Class II
Jul 13, 2020 VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro... Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS Bu... Class II
May 11, 2020 VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product... Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprec... Class II
May 11, 2020 VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI #... Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprec... Class II
May 11, 2020 VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Produc... Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprec... Class II
May 11, 2020 VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # ... Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprec... Class II
Apr 1, 2020 VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8... The Spanish and Swedish language versions of the IFU state that the assay can... Class II
Apr 1, 2020 VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 80011... The Spanish and Swedish language versions of the IFU state that the assay can... Class II
Sep 10, 2019 VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Uri... Users may experience intermittent slide dispense issues with some cartridges ... Class II
Sep 10, 2019 VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which c... Users may experience intermittent slide dispense issues with some cartridges ... Class II
Sep 10, 2019 VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT sup... Users may experience intermittent slide dispense issues with some cartridges ... Class II
Jun 17, 2019 VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chem... Potentially Biased Results using VITROS Chemistry Products GLU Slides Class II
Apr 8, 2019 VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) ... Potential negative drift in Creatine Kinase (CK) results when used on the VIT... Class II
Apr 8, 2019 VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 107587... Potential negative drift in Creatine Kinase (CK) results when used on the VIT... Class II
Apr 8, 2019 VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) ... Potential negative drift in Creatine Kinase (CK) results when used on the VIT... Class II
Apr 8, 2019 VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) ... Potential negative drift in Creatine Kinase (CK) results when used on the VIT... Class II
Mar 20, 2019 VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 684446... Potential for sample fluid to be dispensed to an incorrect position on the Mi... Class II
Mar 11, 2019 VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 ... One of the software algorithms used to detect sample dispense errors was inad... Class II
Feb 20, 2019 VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product ... Luminometer Malfunction May Cause Inability to Process MicroWell Assays on V... Class II
Feb 20, 2019 VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 684... Luminometer Malfunction May Cause Inability to Process MicroWell Assays on V... Class II
Feb 20, 2019 VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For... Luminometer Malfunction May Cause Inability to Process MicroWell Assays on V... Class II
Feb 20, 2019 VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product... Luminometer Malfunction May Cause Inability to Process MicroWell Assays on V... Class II
Feb 20, 2019 VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802... Luminometer Malfunction May Cause Inability to Process MicroWell Assays on V... Class II
Feb 20, 2019 VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use ... Luminometer Malfunction May Cause Inability to Process MicroWell Assays on V... Class II
Feb 20, 2019 VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 680278... Luminometer Malfunction May Cause Inability to Process MicroWell Assays on V... Class II
Jan 22, 2019 VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro ... Imprecision in the affected lot may produce negatively or positively biased p... Class II
Dec 11, 2018 VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only... Negative bias results when using VITROS VALP Reagent, GEN 25. Class II
Nov 1, 2018 VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qua... The firm is extending their previous July 2018 recall to include additional p... Class II
Nov 1, 2018 VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in v... The firm is extending their previous July 2018 recall to include additional p... Class II
Nov 1, 2018 VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro dia... The firm is extending their previous July 2018 recall to include additional p... Class II
Oct 19, 2018 VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vi... Software anomaly may incorrectly extend the on-analyzer stability time for a ... Class II
Oct 19, 2018 VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vit... Software anomaly may incorrectly extend the on-analyzer stability time for a ... Class II
Oct 19, 2018 VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in th... Software anomaly may incorrectly extend the on-analyzer stability time for a ... Class II
Oct 19, 2018 VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vit... Software anomaly may incorrectly extend the on-analyzer stability time for a ... Class II
Oct 8, 2018 VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to ... VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results Class II
Aug 28, 2018 VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number... The reagent pack exhibits the potential for an increased frequency of calibra... Class II
Aug 15, 2018 VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quan... Potential for the VITROS 5600 Integrated System to dispense an insufficient s... Class II
Aug 15, 2018 VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quanti... Potential for the VITROS 5600 Integrated System to dispense an insufficient s... Class II
Jul 11, 2018 VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage:... The slides failed to meet current claims for Limit of Blank (LoB), Limit of D... Class III
Jul 11, 2018 VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage ... The slides do not meet the maximum allowable interference (MAI) claims for tr... Class III
Jul 11, 2018 VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usag... The slides did not meet the current claims for Limit of Blank (LoB), Limit of... Class III
Jul 11, 2018 VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage:... The slides do not meet the maximum allowable interference (MAI) claims for tr... Class III
May 9, 2018 VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diag... There is a potential for imprecise results when using the slides. Increase i... Class II
May 5, 2018 VITROS Sodium Slides, Catalog # 837 9034 Potential for positively biased results Class II

View all 199 device recalls →

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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