Company: Beckman Coulter Inc
Date of Enforcement Report: 3/24/04
Class: II
PRODUCT
a) CXP software, Part No. 623560. Recall # Z-0635-04;
b) Cytomics MXP Software, Part No. 623688.
Recall # Z-036-04;
c) Cytomics RXP Software, Part Numbers: 175488, 6418489,
175260, 175261, 175262, 175263, 175264, 175265.
Recall # Z-0637-04.
REASON
Software anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using the FlowPAGE print format, will have the fixed Sample ID and Run Date, rather than the correct Sample ID and Run Date.
CODE
a), b) and c) Version 1.0.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc, Brea, CA, by modified operating instructions on February 13, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
418.
DISTRIBUTION
Nationwide and Canada.
