Product Wiki · Recalls · Health Canada — Medical Devices

Hemochron Signature Elite (2020-01-30) — recall 63221

Health Canada — Medical Devices · Canada · 2020-03-13 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
63221
Date of alert
2020-03-13
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Accriva Diagnostics has identified that some Hemochron Signature Elite Analyzers may not maintain a temperature of 37°C ±1.0°C degrees in some operating environments as outlined in the operators manual (P/N HX1101). Software version 2.4 has been developed to ensure that the Hemochron Signature Elite maintains a temperature of 37°C ±1.0°C throughout the duration of the assay.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/hemochron-signature-elite-2020

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