Company: Beckman Coulter, Inc
Date of Enforcement Report:8/2/2006
Class:lI
PRODUCT
Beckman Coulter Cytomics FC 500 Flow Cytometry System, Part Numbers 626553 (TN; FC500 with UPS), 6605627 (TN; 5 CLR, FC500 (100V), 6605628 (TN; 5CLR, FC500 (120V), 6605629 (TN; 5 CLR, FC500 (220V), 6605630 (TN; 5 CLR, FC500 (240V) with CXP Software Versions 2.0 and 2.1, Recall # Z-1259-06
REASON
Beckman Coulter has determined that under certain conditions a system error generated during a Pause and rotate routine may result in a sample misidentification with a risk of reporting erroneous results.
CODE
Software Versions 2.0 and 2.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter on May 22, 2006.
Manufacturer: Applied Cytometry, Sheffield, United Kingdom. Firm initiated recall is ongoing..
VOLUME OF PRODUCT IN COMMERCE
424 devices
DISTRIBUTION
Nationwide and Canada
