Company: Sunquest Information Systems, Inc
Date of Enforcement Report: 4/24/02
Misys Laboratory for Windows version 5.3. Recall # Z-0888-2.
Software QA code of BOTH for patient sex can result in QA flags not being generated for abnormal results.
Sunquest Information Systems, Inc., aka Misys Healthcare Systems Tucson,
AZ, by a temporary procedural workaround March 8, 2002.Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide, internationally to United Kingdom, Ireland, Denmark, Canada, Bermuda and Saudi Arabia.