09
Jan
2004

Information Data Management

0

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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