10
Aug
2005

Inc. Class II Beckman Coulter

0

Company: Beckman Coulter, Inc.
Date of Enforcement Report: 8/10/05
Class: II

PRODUCT
StemCXP Software, version 1.0 for Cytomics FC 500, Recall # B-1738-5

REASON
StemCXP Software, which had a glitch or defect, was distributed.

CODE
Version 1.0

RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter dated February 24, 2005.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
1 unit

DISTRIBUTION
FL, IA, IL, MA, and Canada

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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