Product Wiki · Recalls · Health Canada — Medical Devices

Stratus CS Acute Care System Cardiac troponin-i TestPak (2019-06-04) — recall 59220

Health Canada — Medical Devices · Canada · 2019-06-21 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
59220
Date of alert
2019-06-21
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Increased rate of false positive cTnI results beginning 2 months prior to the end of the product's shelf life due to a positive bias and increased imprecision. Increased rate of random non-repeatable false positive cTnI results at any time in the product's shelf life.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/stratus-cs-acute-care-system-c

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