Medical Device Notification (PSN-08-06) - Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc.

DATE NOTIFICATION INITIATED:

August 15, 2008

PRODUCT / LOT NUMBER:

Sunquest Blood Bank and Blood Donor version 6.0.1 distributed with Sunquest Laboratory 6.1 and 6.2; Sunquest Blood Bank and Blood Donor version 6.0.2 distributed with Sunquest Laboratory 6.3

MANUFACTURER:

Sunquest Information Systems, Inc.
Tucson, Arizona

REASON:

In the Blood Order Processing module when at least two tests are added to a unit in the Compatibility Testing window, under specialized situations, the system will save result(s) with incorrect records. Customers are asked to request the software correction via the Client Support web page.

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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.