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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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


August 15, 2008


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


Sunquest Information Systems, Inc.
Tucson, Arizona


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.


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.


Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002