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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Medical Device Notification (PSN-08-05) - Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest InformationSystems, Inc.

DATE NOTIFICATION INITIATED:

June 24, 2008

PRODUCT / LOT NUMBER:

Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1, v6.0.2, and v6.4.0 (Beta)
Distributed with Sunquest Laboratory v6.1, v6.2, v6.3 and v6.3.1 (Beta)

MANUFACTURER:

Sunquest Information Systems, Inc.
Tucson, Arizona

REASON:

In the Blood Order Processing Worklist, only in specialize situations, data being entered may be out of sync and saved to a patient other than the one expected. 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