Company: Beckman Coulter, Inc
Date of Enforcement Report: 12/15/04
Class: III
PRODUCT
CXP software for Cytomics FC500 Cytometer. Recall # Z-0266-05.
REASON
Incorrect sample identification can be displayed and printed on the Runtime Panel Report due to a software defect.
CODE
Versions 1.0, 1.1, and 2.0.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter of November 8, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
167.
DISTRIBUTION
Nationwide and Canada.
