Medical Device Notification (PSN-08-03) for 5.x and Addendum

Sunquest Laboratory Blood Bank and Blood Donor Modules

DATE NOTIFICATION INITIATED:

June 5, 2008

PRODUCT / LOT NUMBER:

Sunquest Laboratory Blood Bank and Blood Donor Modules v5.2
Distributed with Sunquest Laboratory v5.3. and v5.4

Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1, v6.0.2, and v6.4.0 (Beta)
Distributed with Sunquest Laboratory v6.1, v6.2, v6.3 and v6.3.1 (Beta)

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 (March 26 , 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.