Medical Device Notification (PSN-08-02)
Sunquest Laboratory Blood Bank and Blood Donor Modules
DATE NOTIFICATION INITIATED:
February 11, 2008
PRODUCT:
Sunquest Laboratory Blood Bank and Blood Donor Modules 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 both the Blood Bank and Blood Donor modules, a problem has been identified in Blood Order Processing. The system does not trigger all Quality Assurances messages when reaction result grids are enabled. 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.