Company: Sunquest Laboratory System
Date of Enforcement Report 12/10/2008
Class:ll
PRODUCT
Sunquest Laboratory Blood Bank and Blood Donor version 6.0.1 Distributed with Sunquest Laboratory 6.1 and 6.2 and Sunquest Laboratory Blood Bank and Blood Donor version 6.0.2 Distributed with Sunquest Laboratory 6.3, Recall # B-0149-09
REASON
Software, with a glitch or defect, was distributed.
RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc., Tucson , AZ , by Product Safety Notice issued on September 30, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
286 units
DISTRIBUTION
Nationwide, Canada , Bermuda , Ireland , United Kingdom , United Arab Emirates