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Vaccines, Blood & Biologics

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

DATE NOTIFICATION INITIATED:

March 26, 2008

PRODUCT / LOT NUMBER:

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 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 (June 5, 2008)

    
 

Contact Us

  • (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

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