Company: Sunquest Information Systems, Inc
Date of Enforcement Report: 1/23/02
Class: II
PRODUCT
FlexiLab? Blood Bank and Blood Donor Software (3 versions), Recall # B-0627-2.
REASON
Blood establishment computer software that could allow the release of unsuitable blood products was distributed.
CODE
Version numbers 5.2, 5.23, and 5.3.
RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc., Tucson, AZ, by letter on Aug. 24, 2001. Firm initiated recall ongoing.
VOLUME OF PRODUCT IN COMMERCE
3 versions.
DISTRIBUTION
Nationwide and Canada, United Kingdom, Ireland, Saudi Arabia and Bermuda