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
- ocod@fda.hhs.gov
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

