OTTAWA, July 16, 2016 /CNW/ - The issue:
Alere Inc. is withdrawing the Alere INRatio® andINRatio®2 Prothrombin Time Monitoring Systems (professional and self-test) devices from the Canadian market. These devices measure blood clotting time in patients requiring warfarin and other oral blood-thinning medicines.
Alere INRatio® and INRatio®2 PT/INR Monitor Systems:
Who is affected:
Patients and healthcare professionals using the Alere INRatio® and INRatio® 2 PT professional use and self-test use Monitoring Systems to determine INR levels for monitoring the effect of warfarin on clotting time.
What consumers should do
What Health Canada is doing:
Health Canada is communicating this information to healthcare professionals and to the public. Health Canada is working with the manufacturer and closely monitoring the situation and the implementation of necessary corrective and preventative actions.
In 2014, Alere initiated a voluntary recall action to inform users of the INRatio® Patient Self-Testing Monitoring System, INRatio® PT Monitoring System (Professional Use) and INRatio® Prothrombin Time/INR Strips that they may provide an INR result that, in certain cases, is significantly lower than a result obtained using a laboratory INR system. That recall can be found here: http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/42959r-eng.php.
How to report side effects to health products to Health Canada:
Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.
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SOURCE Health Canada
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