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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Medical Device Notification (PSN-08-03) - Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc.

DATE NOTIFICATION INITIATED:

June 5, 2008

PRODUCT / LOT NUMBER:

Sunquest Laboratory Blood Bank and Blood Donor Modules v5.2
Distributed with Sunquest Laboratory v5.3. and v5.4

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 both the Blood Bank and Blood Donor modules, a problem has been identified when a pooled unit is pooled with another unit. The system does not trigger all Quality Assurances messages. The problem only occurs in specialized situations. Customers are asked to request the software correction via the Client support Webpage.

Medical Device Notification Dated (March 26, 2008)

 

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