Medical Device Notification (PSN-08-03)
Sunquest Laboratory Blood Bank and Blood Donor Modules
DATE NOTIFICATION INITIATED:
March 26, 2008
PRODUCT / LOT NUMBER:
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 when a pooled unit is pooled with another unit. The system does not trigger all Quality Assurances messages. The problem only occurs in specialized situations. Customers are asked to request the software correction via the Client support Webpage.
Medical Device Notification Dated (June 5, 2008)
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.