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.
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.
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