Company: Beckman Coulter Inc
Date of Enforcement Report 1/21/2009
Class:ll
PRODUCT
Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553. This product is used for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file, Recall # Z-0129-2009
REASON
Software error: The CXP software does not refresh the dataset automatically under certain circumstances. The User documentation does not clearly state that the user should refresh the dataset after changes is made.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter dated October 17, 2007.
Manufacturer: Beckman Coulter, Inc., Fullerton, CA. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
594 units
DISTRIBUTION
Nationwide and Canada
