Vaccines, Blood & Biologics
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Medical Device Notification: Sunquest Laboratory Blood Bank Module - Sunquest Information Systems, Inc
DATE NOTIFICATION INITIATED:
December 14, 2007
PRODUCT
Sunquest Laboratory Blood Bank Module 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 the Sunquest Blood Bank module, a problem has been identified in Blood Order Processing and Blood Product Testing. The system does not trigger all Quality Assurance warnings/failures when there is a mismatch between the reaction results and the interpretation. The problem only occurs in specialized situations. Customers are asked to request the software correction via the Client support Webpage.
Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
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

