Company: Misys Healthcare Systems.
Date of Enforcement Report: 1/21/04
Class: II
PRODUCT
Calculator/Data Processing Module for Clinical Use. Recall
# Z-0235-04.
REASON
Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks.
CODE
Versions 5.2, 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by facsimile on September 25, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
485.
DISTRIBUTION
Nationwide and Internationally.
