Company: Beckman Coulter, Inc.,
Date of Enforcement Report:3/8/2006
Class:lI
PRODUCT
UniCel Dxl 800 Access Immunoassay System, Recall # Z-0583-06
REASON
The UniCel Dxl 800 Access Immunoassay may aspirate a sample from an incorrect rack and generate a result, which is not flagged (under a specific set of circumstances)
CODE
Software Versions 2.2.1 and earlier
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter the week of February 6, 2006.
Manufacturer: Beckman Coulter, Inc., Chaska, MN, firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
280 units
DISTRIBUTION
Nationwide and Canada
