Company: Information Data Management
Date of Enforcement Report: 1/9/04
DATE RECALL INITIATED:
January 9, 2004
PRODUCT / VERSIONS:
IDM Surround System, Software versions 3.4, 3.5, and 3.6
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.
MANUFACTURER:
Information Data Management
Rosemont, IL
