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