Company:Beckman Coulter Inc., Brea, CA
Date of Enforcement Report:9/13/2006
Class:ll

PRODUCT
FP1000 Cell Preparation System Part Number 624922, Recall # Z-1466-06

REASON
During the cleaning cycle performed during the shutdown procedure of the Beckman Coulter FP1000 Cell Preparation System, fluid (diluted bleach) may drip from the probe in the location of the back reagent rack potentially resulting in bleach and/or water dripping into the reagents contaminating them and resulting in possible incorrect results.

CODE
Software Version 1.0

RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on June 26, 2006.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
11 units

DISTRIBUTION
Nationwide and Canada