FDA Logo links to FDA home page
Center for Biologics Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Biologics Evaluation and Research
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | CBER A-Z Index | CBER Search | Contact CBER | CBER Home Page

horizontal rule
CBER links to product areas Blood Vaccines Cellular/Gene Therapy Tissue Devices
CBER links Products Industry Healthcare Reading Room Meetings What's New
horizontal rule

Recall of Blood Bank Data Management System Software
Information Data Management

horizontal rule

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.

horizontal rule

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

 

 
horizontal rule