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Ortho-Clinical Diagnostics, Inc. recall records

65 reported ongoing

66 records in this archive. Latest source date Jul 29, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitat...

Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its true expiration and the customer does not have their Assay Data Disk (ADD) updated, the system will allow them ...

Class IIIReported ongoing

Distribution: Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, ...

Official source
FDA device enforcement

VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic...

The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the required range during processing of RV...

Class IIIReported ongoing

Distribution: Worldwide - US Nationwide and the country of Columbia.

Official source
FDA device enforcement

VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).

Potential for positively biased results due to signal reduction over shelf life.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA,...

Official source
FDA device enforcement

VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

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.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil...

Official source
FDA device enforcement

VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)

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.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil...

Official source
FDA device enforcement

VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)

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.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil...

Official source
FDA device enforcement

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.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil...

Official source
FDA device enforcement

VITROS XT 7600 Integrated System, Catalog No. 6844461

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.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil...

Official source
FDA device enforcement

VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reporte...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, No...

Official source
FDA device enforcement

VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reporte...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, No...

Official source
FDA device enforcement

VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reporte...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, No...

Official source
FDA device enforcement

VITROS XT 3400 Chemistry System, Catalog No. 6844458

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reporte...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, No...

Official source
FDA device enforcement

VITROS XT 7600 Integrated System, Catalog No. 6844461

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reporte...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, No...

Official source
FDA device enforcement

VITROS 3600 Immunodiagnostic System (New and Refurbished)

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.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, M...

Official source
FDA device enforcement

VITROS 5600 Integrated System (New and Refurbished)

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.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, M...

Official source
FDA device enforcement

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.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, M...

Official source
FDA device enforcement

VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926

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

Class IIReported ongoing

Distribution: Domestic distribution nationwide. OUS distribution to Bermuda, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Sp...

Official source
FDA device enforcement

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...

Class IIReported ongoing

Distribution: Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.

Official source
FDA device enforcement

VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in ...

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 interm...

Class IIReported ongoing

Distribution: Nationwide Foreign: Bermuda Canada

Official source
FDA device enforcement

VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0

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 wa...

Class IIReported ongoing

Distribution: US Nationwide. Global Distribution.

Official source

Reasons in these listed records

  • Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its true expiration and the customer does not have their Assay Data Disk (ADD) updated, the system will allow them to use the expired c...
  • The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the required range during processing of RV Level 2 of this lot...
  • Potential for positively biased results due to signal reduction over shelf life.
  • 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.

These examples come from this result page and are not a ranking of every recall reason.

Checking Ortho-Clinical Diagnostics, Inc.

Is there a recall on ortho-clinical diagnostics, inc. right now?

This archive contains 66 records, including 65 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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