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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.

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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.

 

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