Oct

2001

Bayer Corporation Class III

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Bayer Corporation Class III

Amy Sellers

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