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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
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448