Company: Beckman Coulter, Inc.,
Date of Enforcement Report:7/26/2006
Class:lI
PRODUCT
Coulter LH500 Hematology Analyzer; Part Numbers 178832, 178833 and 178834, Recall # Z-1245-06
REASON
Beckman has confirmed that erroneous results could be reported when the workstation data base crashes.
CODE
All software versions
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter sent week of April 17, 2006.
Manufacturer: Beckman Coulter, Inc., Miami, FL.Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
759 units
DISTRIBUTION
Nationwide and Canada