Product Wiki · Recalls · Health Canada — Medical Devices

Coaguchek XS Strips (2018-10-10) — recall 58466

Health Canada — Medical Devices · Canada · 2018-11-28 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
58466
Date of alert
2018-11-28
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Since the new WHO reference standard rtf/16 is used for calibration of the CoaguChek XS strips, measurement deviations against non-Roche controls as well as laboratory methods for higher INR values have been documented. For values higher than 4.5 INR increasing positive bias was found for identified lots.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/coaguchek-xs-strips-2018-10-10

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