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.
