Aug

2002

Bayer Corporation Class III

Company: Bayer Corporation
Date of Enforcement Report: 8/21/02
Class: III

PRODUCT
Brand Name: ADVIA Centaur(R) Analyzer. Recall # Z-1233-2.

REASON
Software programming error.

CODE
All serial numbers distributed with Model/Part Number 572561, along with all existing software versions from 2.1 to 2.5.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer Corporation, Business Group Diagnostics, Tarrytown, NY, by letter on March 13, 2002.
Manufacturer: Bayer Diagnostics Manufacturing Limited, Swords County, Dublin. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2275 units.

DISTRIBUTION
Nationwide and Internationally.

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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