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.
