Recall of Medical Device Notification (PSN-08-01)

Sunquest Laboratory Blood Bank and Blood Donor Modules

DATE NOTIFICATION INITIATED:

January 23, 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 the Sunquest Blood Bank and Blood Donor Modules, a problem has been identified in Blood Product Testing. If the user chooses to delete and unacceptable product test result by replacing it with another unacceptable product test result, then cancels and saves, the system incorrectly retains the initial result instead of leaving the product test pending. 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.