Company: Misys Healthcare Systems
Date of Enforcement Report: 8/27/03
Class: II
PRODUCT
Misys Laboratory System versions 5.3 up to 5.3.2 with Lab Access Results Workstation. Recall # Z-1093-03.
REASON
Software defect. When Quality Assurance failure warnings are missing from a patient’s report abnormal results could be used for diagnosis or treatment.
CODE
Versions 5.3 up to 5.3.2.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on June 23, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
157.
DISTRIBUTION
Nationwide, United Kingdom, Ireland, Canada, Denmark, Saudi Arabia.
