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Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics Recalls

All product recalls associated with Ortho-Clinical Diagnostics.

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Recall Summary

Total Recalls

133

Past Year

Class I (Serious)

Most Recent

Jul 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 133 recalls

Ortho-Clinical Diagnostics: VITROS Performance Verifier I

The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.

FDAFeb 27, 2024Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics, Inc.: VITROS XT 3400 Chemistry System, Catalog No. 6844458

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS 5600 Integrated System Catalog Nos. 6802413 (regul...

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FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS 4600 Chemistry System Catalog Nos. 6802445 (regula...

FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 ...

FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS XT 7600 Integrated System, Catalog No. 6844461

FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS XT7600 Integrated System

Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

FDAJan 22, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS 5600 Integrated System (New and Refurbished)

FDAJan 22, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS 3600 Immunodiagnostic System (New and Refurbished)

FDAJan 22, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS Immunodiagnostic Products Anti-HBs Quantitative Re...

Affected lots may experience increased calibration failures or an increase in falsely elevated results.

FDANov 27, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: QMS Tacrolimus Calibrators, Product code 10015573

Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of the calibrator and render it unsuitable for use. Use of the affected lot may results in erroneous calibration results, causing delay in testing.

FDANov 21, 2023FL, IL, IN +3 more• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, INc.: VITROS Chemistry Products ECO2 Slides-For in vitro diagno...

Laceration Risk

Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of VITROS ECO2 slides included carts which may contain consecutive slides that may not function as intended. These affected slides (potentially intermittent, consecutive slides within a cart or across consecutive carts) have an abnormality which may cause positively or negatively biased total carbon dioxide (CO2) results leading to either overdiagnosis of acidosis or missing alkalosis, both which may prompt unnecessary therapies such as IV fluids and/or bicarbonate or overdiagnosis of alkalosis which may also result in unnecessary use of IV fluids and electrolyte replacement or failure to detect acidosis and necessary treatment.

FDAOct 25, 2023Nationwide• Ortho-Clinical Diagnostics, INc.

Ortho-Clinical Diagnostics, Inc.: VITROS 3600 Immunodiagnostic System Product Code 6802783 ...

During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.

FDAOct 10, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS XT 3400 Chemistry System Product Code 6844458 Runn...

FDAOct 10, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS XT 7600 Integrated System Product Code 6844461 Run...

FDAOct 10, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS 4600 Chemistry System Product Code 6802445 and Ref...

FDAOct 10, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS 5600 Integrated System Product Code 6802413 and Re...

FDAOct 10, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, INc.: VITROS Chemistry Products Lipase Slides, Product Codes 16...

Laceration Risk

Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsely low levels could result in a missed or delayed diagnosis of acute pancreatitis and may lead to diagnostic confusion in the setting of acute abdominal symptoms. Falsely elevated levels would not result in patient harm but may cause diagnostic confusion and a delay in accurate diagnosis of a patient with abdominal pain.

FDASep 12, 2023CA, CO, FL +9 more• Ortho-Clinical Diagnostics, INc.

Ortho-Clinical Diagnostics, Inc.: Proboscis/Piston Assembly, Part Number J55375, for VITROS...

Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification barrel component. This may cause VITROS VersaTips and/or VITROS MicroTips to be improperly seated on the proboscis, which may result in falsely elevated Gentamicin and Valproic Acid assay results as well as an increased frequency of condition codes resulting in delayed patient results. The issue was identified by internal testing when reported instruments failed to pass release testing and were traced to the molded Proboscis part J56639 with date codes from 040722 onward.

FDAAug 9, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, INc.: VITROS XT Chemistry Products TBIL-ALKP Slides

Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.

FDAAug 5, 2023Nationwide• Ortho-Clinical Diagnostics, INc.