Product Wiki · Recalls · Health Canada — Medical Devices

INRatio Patient Self-Testing Monitoring System, INRatio PT Monitoring… — recall 52819

Health Canada — Medical Devices · Canada · 2014-12-18 · Type I

As described by Health Canada — Medical Devices: INRatio Patient Self-Testing Monitoring System, INRatio PT Monitoring System (Professional Use) and INRatio Prothrombin Time/INR Strips (2014-12-09)

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
52819
Date of alert
2014-12-18
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: In certain cases an INRatio PT/INR monitor system may provide an INR result that is significantly lower than a result obtained using a laboratory INR system. The plasma-based laboratory INR method is considered the most accurate and reliable INR method.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/inratio-patient-self-testing-m

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