Company: Beckman Coulter Inc
Date of Enforcement Report 1/14/2009
Class:ll
PRODUCT
Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2, Recall # Z-0455-2009
REASON
Software error: The CXP User documentation does not adequately characterize the use of the Live Gate feature.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on July 23, 2007.
Manufacturer: Applied Cytometry, Sheffield, UK. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
565 units
DISTRIBUTION
Nationwide and Canada
