May

2003

Inc. Class III Beckman Coulter

Company: Beckman Coulter, Inc.
Date of Enforcement Report: 5/28/03
Class: III

PRODUCT
COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use. Recall # Z-0805-03.

REASON
Software problem may cause the instrument to skip the probe-wash step before processing different reagents.

CODE
All existing versions of the software. Serial numbers PrepPlus 0006026440 and above PrepPlus 2 0109079674 and above.

RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter on March 28, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
98.

DISTRIBUTION
Nationwide and Canada.

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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Inc. Class III Beckman Coulter

Amy Sellers

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