Company: Misys Healthcare Systems
Date of Enforcement Report: 9/17/03
Class: II
PRODUCT
Misys Laboratory System. Recall # Z-1217-03.
REASON
Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported.
CODE
Version 5.2 through 5.3.2 using LabAccess Results.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on July 22, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
171.
DISTRIBUTION
Nationwide and Internationally.