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

Starting date:

July 16, 2016

Posting date:

July 16, 2016

Type of communication:

Information Update

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public

Identification number:

RA-59430

• 
  Issue
• 
  Products affected
• 
  What you should do
• 
  Who is affected
• 
  Background
• 
  Report health or safety concerns
• 
  Media enquiries
• 
  Public enquiries
• 
  What Health Canada is doing

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.

Products affected

Alere INRatio® and INRatio®2 PT/INR Monitor Systems:

• INRatio Patient Self-Test Kit
• INRatio PT Professional  Kit
• INRatio2 Prothrombin Time (PT) Monitoring System, Professional
• INRatio 2 Prothrombin Time (PT) Monitoring System, Self-Test
• INRatio/INRatio 2 Prothrombin Time/INR Test Strips

What you should 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.

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.

Background

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.

Report health or safety concerns

• Call toll-free at 1-866-234-2345
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

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Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

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.