19
May
2004

Inc. Class II Beckman Coulter

0

Company: Beckman Coulter, Inc.
Date of Enforcement Report: 5/19/04
Class: II

PRODUCT
Coulter LH750 Hematology Analyzer. Part Number 6605632.
Recall # Z-0905-04.

REASON
If a customer enters a dilution factor for Sample B prior to the results from Sample A being transferred to the workstation, the predilute multiplication factor will be applied erroneously to the Sample A’s results once they are received at the workstation.

CODE
Software versions 2A2 and 2B1.

RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letters on March 31, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
981.

DISTRIBUTION
Nationwide 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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