21

Jan

2025

FDA Recall: Software Error MAy Not Notify Users of Expiration Date

0

Company: Ortho-Clinical Diagnostics, INC.
Date of Enforcement Report: 1/21/2025
Class II

PRODUCT

Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component

Recall Number:

Z-1006-2025

REASON:

The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.

RECALLING FIRM/MANUFACTURER:

Ortho-Clinical Diagnostics, INC.

VOLUME OF PRODUCT IN COMMERCE:

1,893 units (994 US, 899 OUS)

DISTRIBUTION:

Worldwide distribution – US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.

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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