Inc. Class III Beckman Coulter

Company: Beckman Coulter, Inc.
Date of Enforcement Report: 9/10/03
Class: II

PRODUCT
Access Immunoassay System Technical Update 03.1, Part number 387851. Recall # Z-1148-03.

CODE
Software version 3.29.

RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA., by telephone between June 18, 2003 and July 3, 2003. Firm initiated recall is ongoing.

REASON
Defective software media distributed with upgrade software may cause installation failure and systems lock.

VOLUME OF PRODUCT IN COMMERCE
1,615.

DISTRIBUTION
Nationwide.

About the author

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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