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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Medical Device Notification: Sunquest Laboratory Blood Bank Module - Sunquest Information Systems, Inc

DATE NOTIFICATION INITIATED:

December 14, 2007

PRODUCT

Sunquest Laboratory Blood Bank Module 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 module, a problem has been identified in Blood Order Processing and Blood Product Testing. The system does not trigger all Quality Assurance warnings/failures when there is a mismatch between the reaction results and the interpretation. The problem only occurs in specialized situations. Customers are asked to request the software correction via the Client support Webpage.

 

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