Ortho-Clinical Diagnostics, Inc.

Complete recall history across all FDA and CPSC categories — 71 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 (71)

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

Date Product Reason Class
Jul 29, 2025 Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contai... VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Sys... Class II
Jul 29, 2025 VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit =... VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Sys... Class II
Jul 9, 2025 VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261; Generations 67 and above of VITROS Ca Slides are experiencing an increased oc... Class II
Jun 12, 2025 VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITR... Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may gen... Class II
Jun 10, 2025 VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 ... Quality control (QC) drift when certain lots of Performance Verifiers (PVs) a... Class II
Jun 10, 2025 VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 sli... Quality control (QC) drift when certain lots of Performance Verifiers (PVs) a... Class II
Jun 10, 2025 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... Quality control (QC) drift when certain lots of Performance Verifiers (PVs) a... Class II
Jun 10, 2025 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... Quality control (QC) drift when certain lots of Performance Verifiers (PVs) a... Class II
May 9, 2025 Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalo... A software anomaly allows test results to be reported using Micro Tip and Mic... Class II
May 9, 2025 Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog... a software anomaly allows test results to be reported using Micro Tip and Mic... Class II
May 9, 2025 Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/C... a software anomaly allows test results to be reported using Micro Tip and Mic... Class II
Apr 14, 2025 VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, o... Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, ... Class II
Mar 24, 2025 Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetell... It was determined that there could be a false positive rate of up to 16.7% fo... Class II
Dec 19, 2024 Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/... The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not corre... Class II
Dec 19, 2024 Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalo... The VITROS 5600 Integrated System software versions 3.8.0 may not correctly n... Class II
Dec 19, 2024 Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Cat... The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctl... Class II
Oct 11, 2024 VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively meas... May Generate Negatively Biased Results When Testing Samples with High Concent... Class II
Jul 10, 2024 The VITROS XT Chemistry Products ALB-TP Slides is a single device that contai... The reason for this recall is QuidelOrtho has determined that during normal u... Class II
Jul 3, 2024 VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 It was confirmed that fibrinogen in patient plasma samples precipitates out o... Class II
May 21, 2024 VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. ... VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to... Class II
May 14, 2024 VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the V... Kit assigned an extended expiration date of 24-Jul-2025 during release. The c... Class III
May 8, 2024 VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagno... The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Ran... Class III
Mar 1, 2024 VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Ca... Potential for positively biased results due to signal reduction over shelf life. Class II
Jan 26, 2024 VITROS XT 3400 Chemistry System, Catalog No. 6844458 A software defect affecting VITROS Systems running VITROS Software Versions 3... Class II
Jan 26, 2024 VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 680291... A software defect affecting VITROS Systems running VITROS Software Versions 3... Class II
Jan 26, 2024 VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refu... A software defect affecting VITROS Systems running VITROS Software Versions 3... Class II
Jan 26, 2024 VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (ref... A software defect affecting VITROS Systems running VITROS Software Versions 3... Class II
Jan 26, 2024 VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refu... A software defect affecting VITROS Systems running VITROS Software Versions 3... Class II
Jan 26, 2024 VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 680291... A software defect affecting VITROS Systems running VITROS Software Versions 3... Class II
Jan 26, 2024 VITROS XT 7600 Integrated System, Catalog No. 6844461 A software defect affecting VITROS Systems running VITROS Software Versions 3... Class II
Jan 26, 2024 VITROS XT 3400 Chemistry System, Catalog No. 6844458 A software defect affecting VITROS Systems running VITROS Software Versions 3... Class II
Jan 26, 2024 VITROS XT 7600 Integrated System, Catalog No. 6844461 A software defect affecting VITROS Systems running VITROS Software Versions 3... Class II
Jan 26, 2024 VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (ref... A software defect affecting VITROS Systems running VITROS Software Versions 3... Class II
Jan 22, 2024 VITROS 3600 Immunodiagnostic System (New and Refurbished) Potential For Aspiration from Unintended Sample Container During Sampling Cen... Class II
Jan 22, 2024 VITROS XT7600 Integrated System Potential For Aspiration from Unintended Sample Container During Sampling Cen... Class II
Jan 22, 2024 VITROS 5600 Integrated System (New and Refurbished) Potential For Aspiration from Unintended Sample Container During Sampling Cen... Class II
Nov 27, 2023 VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog ... Affected lots may experience increased calibration failures or an increase in... Class II
Nov 21, 2023 QMS Tacrolimus Calibrators, Product code 10015573 Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot... Class II
Oct 25, 2023 VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITR... Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing tha... Class II
Oct 10, 2023 VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Prod... During planned monitoring of data post-release of Software Version 3.8.0 an i... Class II
Oct 10, 2023 VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Co... During planned monitoring of data post-release of Software Version 3.8.0 an i... Class II
Oct 10, 2023 VITROS XT 7600 Integrated System Product Code 6844461 Running Software Versio... During planned monitoring of data post-release of Software Version 3.8.0 an i... Class II
Oct 10, 2023 VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Cod... During planned monitoring of data post-release of Software Version 3.8.0 an i... Class II
Oct 10, 2023 VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version... During planned monitoring of data post-release of Software Version 3.8.0 an i... Class II
Sep 12, 2023 VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 S... Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnorma... Class II
Aug 9, 2023 Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry Sy... Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston A... Class II
Aug 5, 2023 VITROS XT Chemistry Products TBIL-ALKP Slides Samples containing high levels of ALKP (or an interfering substance) could de... Class II
Aug 5, 2023 VITROS XT Chemistry Products ALKP Slides Samples containing high levels of ALKP (or an interfering substance) could de... Class II
May 18, 2023 VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro di... May not meet the stability specifications for shelf life outlined in the Inst... Class III
Apr 17, 2023 VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determi... Potential for both unexpected positive and negative HbA1c results, may resul... Class II

View all 71 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.

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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