Company: Beckman Coulter Inc
Date of Enforcement Report 8/13/2008
Class:ll
PRODUCT
Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles, Recall # Z-1529-2008
REASON
Labeling provided by two integrated software systems are not clear enough to avoid potential demographic and sample type mismatches under certain conditions.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated August 16, 2007.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
141 units
DISTRIBUTION
Nationwide and Internationally
