Sep

2006

Inc., Class II Beckman Coulter

Company: BEckman Coulter Inc.
Date of Enforcement Report:9/6/2006
Class:ll

PRODUCT
UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems, Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4, Recall # Z-1440-6

REASON
Incorrect Reagent Status-When a new cartridge of Infinity Lithium Reagent is loaded on to the UniCel DxC System, the Reagent Status screen will incorrectly show ‘Days Left’ as 21. The correct Reagent Status for a new Lithium reagent cartridge is 14 days. Lithium reagent used past 14 days may produce low quality control and/or patient results.

CODE
Software version 1.0, Software version 1.2, Software version 1.4

RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter the week of May 15, 2006. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
524 units

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 II Beckman Coulter

Amy Sellers

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