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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Medical Device Notification (PSN-08-09)-Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc.

DATE NOTIFICATION INITIATED:

September 30, 2008

PRODUCT / LOT NUMBER:

Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1, v6.0.2
Distributed with Sunquest Laboratory v6.1, v6.2, v6.3

MANUFACTURER:

Sunquest Information Systems, Inc.
Tucson, Arizona

REASON:

In the Blood Order Processing module after the Search button is chosen for a specific accession number, the system allows entry of a second accession number. Under specialized situations, the system will save result(s) with incorrect records. 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