Medical Device Notification (PSN-08-09)
Sunquest Laboratory Blood Bank and Blood Donor Modules
DATE NOTIFICATION INITIATED:
September 30, 2008
PRODUCT / LOT NUMBER:
Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1, v6.0.2
Distributed with Sunquest Laboratory v6.1, v6.2, v6.3
MANUFACTURER:
Sunquest Information Systems, Inc.
Tucson, Arizona
REASON:
In the Blood Order Processing module after the Search button is chosen for a specific accession number, the system allows entry of a second accession number. Under specialized situations, the system will save result(s) with incorrect records. 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.