Product Wiki · Recalls · Health Canada — Medical Devices

UniCel DxH Analysis Systems (2016-04-05) — recall 55061

Health Canada — Medical Devices · Canada · 2016-04-22 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
55061
Date of alert
2016-04-22
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: The DxH 800, DxH 600, and DxH Slidemaker Stainer may fail to notify the user of warnings or error conditions for low or depleted reagent conditions, daily checks failures, LIS disconnection, and printer failures at: - the alert status icon(s) on the system manager - the audible alarm at the system manager - the instrument beacon on the specimen processing module or Slidemaker Stainer the failure may occur when the system manager application is restarted or powered off/on.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/unicel-dxh-analysis-systems-20

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