Vaccines, Blood & Biologics
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Medical Device Notification (PSN-08-09)-Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc.
DATE NOTIFICATION INITIATED:
September 30, 2008
PRODUCT / LOT NUMBER:
Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1, v6.0.2
Distributed with Sunquest Laboratory v6.1, v6.2, v6.3
MANUFACTURER:
Sunquest Information Systems, Inc.
Tucson, Arizona
REASON:
In the Blood Order Processing module after the Search button is chosen for a specific accession number, the system allows entry of a second accession number. Under specialized situations, the system will save result(s) with incorrect records. 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

