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Vaccines, Blood & Biologics

Medical Device Notification: Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc.

DATE NOTIFICATION INITIATED:

February 11, 2008

PRODUCT:

Sunquest Laboratory Blood Bank and Blood Donor Modules 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 both the Blood Bank and Blood Donor modules, a problem has been identified in Blood Order Processing. The system does not trigger all Quality Assurances messages when reaction result grids are enabled. 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

Page Last Updated: 06/27/2013
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