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Health Canada Health products

Alere Inc. initiating voluntary withdrawal of Alere INRatio® and INRatio® 2 PT/INR Monitoring System that may pose serious health risks

Issued July 16, 2016
Issue
Alere Inc. is withdrawing the Alere INRatio® and INRatio®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. There is a risk that the Alere devices provide an inaccurate low reading. This could result in an improper dosage of warfarin or other blood-thinning medications being administered, leading to excessive bleeding, which may result in serious health concerns that could potentially be fatal.
What to do
• Consult with your doctor if you have used this product and have health concerns. • Report any adverse incidents to Health Canada . • Patients should speak with their healthcare providers prior to making any changes to their current PT/INR monitoring practices. • Alere Inc. has also committed to providing further information to patients and healthcare providers to assist them in transitioning to an alternate method of monitoring. Alere Inc. will be providing this information as soon as it is available.