Medical Device Notification (PSN-08-08) - Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc.

DATE NOTIFICATION INITIATED:

July 28, 2008

PRODUCT / LOT NUMBER:

Sunquest Laboratory Blood Bank and Blood Donor Modules v6.01 and v6.02
Distributed with Sunquest Laboratory v6.1, v6.2 and v6.3

MANUFACTURER:

Sunquest Information Systems, Inc.
Tucson, Arizona

REASON:

In the Blood Order Processing module, when the unit compatibility grid is enabled and under specialized situations, the system does not trigger all Quality Assurance messages. 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.