Company:Beckman Coulter, Inc.
Date of Enforcement Report:3/14/2007
Class:ll
PRODUCT
Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5), Recall # Z-0566-2007
REASON
There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the subsequent sample is cycled in Body Fluid mode.
CODE
2B Software (2B3, 2B4 and 2B5)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA., by letter on September 12, 2006.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1987 units
DISTRIBUTION
Nationwide and Canada
