Product Wiki · Recalls · Health Canada — Medical Devices

ACL Top Analyzers – Mandatory Parameter Upgrade — recall 48705

Health Canada — Medical Devices · Canada · 2012-09-17 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
48705
Date of alert
2012-09-17
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 manufacturer is conducting a mandatory parameter upgrade (P-14.8) based on two Fibrinogen-C reporting issues. Issue number one was a result of 3 customer complaints where low abnormal Fibrinogen sample reports were reporting as normal. Issue two was identified by the manufacturer during R&D where high Fibrinogen samples were reported as low.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/acl-top-analyzers-mandatory-pa

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