Medical Device Notification: Sunquest Laboratory Blood Bank Module - Sunquest Information Systems, Inc

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.