Company: Bayer Corporation
Date of Enforcement Report: 10/10/01
Class: III
RECALL NUMBER, PRODUCT AND CODE:
Z-1223-1, Software versions AE through AL (except AI) for the Bayer Advia
Centaur Automated Chemiluminescence Immunoassay System. The affected
software was distributed as a component of the Advia Centaur Automated
Chemiluminescence Immunoassay system. Codes: Software versions AE
through AL, except version AI. Catalog Number: 120535
REASON:
Software defect.
MANUFACTURER/RECALLING FIRM:
Bayer Corporation Tarrytown, NY
RECALLED BY:
Manufacturer, by letter on 1/29/01.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
Nationwide and France, Canada, Belgium, Australia, Sweden and Germany.
QUANTITY:
57 units contain the affected software
