Medical Device Notification (PSN-07-05)
Sunquest Laboratory Blood Bank Module
DATE NOTIFICATION INITIATED:
December 14, 2007
PRODUCT
Sunquest Laboratory Blood Bank Module v6.0.1 and v6.0.2
Distributed with Sunquest Laboratory v6.1, v6.2 and v6.3
MANUFACTURER:
Sunquest Information Systems, Inc.
Tucson, Arizona
REASON:
In the Sunquest Blood Bank module, a problem has been identified in Blood Order Processing and Blood Product Testing. The system does not trigger all Quality Assurance warnings/failures when there is a mismatch between the reaction results and the interpretation. The problem only occurs in specialized situations. Customers are asked to request the software correction via the Client support Webpage.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.