Mar

2024

FDA Recall: Software Not Updating Causing Erroneous Patient Results

Allison Pate

News

fda, recall

Company: Ortho-Clinical Diagnostics, Inc.
Date of Enforcement Report: 3/1/2024
Class II

PRODUCT

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

Recall Number:

Z-1224-2024

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Ortho-Clinical Diagnostics, Inc.

VOLUME OF PRODUCT IN COMMERCE:

1 US; 36 OUS

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, Canada, China, Colombia, India, Mexico, Singapore, United Kingdom, Italy, Spain, Russia, France, and Belgium.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: Software Not Updating Causing Erroneous Patient Results

Allison Pate

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