Company:Beckman Coulter Inc.,
Date of Enforcement Report:1/4/2007
Class:ll
PRODUCT
LFC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313 MPL Hardware Upgrade Kit, Recall # Z-0317-2007
REASON
The ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. Issue limited only to protocols utilizing the Ratio parameter such as LeukoSure and DNA Cell Cycle.
CODE
System with MXP Software Version 2.0 & 2.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on Oct 17, 2006.
Manufacturer: Applied Cytometry, Sheffield, UK. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
37 in the US; 4 to Canada
DISTRIBUTION
Nationwide and Canada
