Product Wiki · Recalls · Health Canada — Medical Devices

Engen Automated Sample Handling System (2014-04-11) — recall 51148

Health Canada — Medical Devices · Canada · 2014-04-30 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
51148
Date of alert
2014-04-30
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: In Engen systems with TC-Automation (TCA) software version 2.6, version 3.2 and version 3.5 configured with bypass modules for Advia Centaur, Abbott Architect, Vitros and/or Tosoh Aia systems, a sample tube carrier being released in the bypass module may not be detected and, therefore, the next sample to be metered may not advance for processing. No error message will be posted if this occurs. The bypass module will stop processing samples indefinitley until an operator detects the issue and intervenes.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/engen-automated-sample-handlin

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