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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Blood Bank Data Management System Software - Information Data Management

DATE RECALL INITIATED:

 

January 9, 2004

 

PRODUCT / VERSIONS:

 

IDM Surround System, Software versions 3.4, 3.5, and 3.6

 

MANUFACTURER:

Information Data Management
Rosemont, IL

 

REASON:

 

IDM's Surround System fails to recognize duplicate batches when used in conjunction with the Abbott PPC (Parallel Processing Center) and the TPC (Total Process Control) mode is utilized. Blood Banks using the TPC mode are advised to monitor and review all retransmitted batches to Surround. The software problem will be corrected with the next version release.

 

 

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