Company: Misys Healthcare Systems, Inc
Date of Enforcement Report: 10/9/02
Class: II
PRODUCT
Cytomics RXP software. Recall # Z-1387-2.
REASON
When analyzing multiple listmode files using a multi-file analysis protocol, incorrect percentage results may occur if “% in Regions” is selected.
CODE
Version 1.0.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, CA, by letters dated May 15, 2002. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
6.
DISTRIBUTION
IL, Germany and Canada.
