Company: Beckman Coulter, Inc
Date of Enforcement Report: 8/24/05
Class: II
PRODUCT
Cytomics FC500 MPL with MXP Software, Recall # Z-1377-05
REASON
Software anomaly. If the laser is shutdown or fluctuates outside of the specification limits, the software continues to run and will not indicate a laser failure, and could therefore cause erroneous results.
CODE
Versions 1.1 and 2.0
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letters on July 13, 2005.
Manufacturer: Applied Cytometry Systems, Dinnington, UK. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
Nationwide
