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

Starting date:

July 22, 2016

Posting date:

July 22, 2016

Type of communication:

Advisory

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public

Identification number:

RA-59526

• 
  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

As Health Canada previously communicated, Alere Inc. is withdrawing the Alere INRatio® and INRatio® 2 Prothrombin Time (PT) Monitoring Systems (professional use and patient 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 Monitoring Systems:

• INRatio Patient Self-Test Kit
• INRatio PT Professional Kit
• INRatio 2 Prothrombin Time (PT) Monitoring System, Professional Use
• INRatio 2 Prothrombin Time (PT) Monitoring System, Patient 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 advised that patients and healthcare providers should transition to another monitoring system; however, they may continue to use the Alere INRatio® or INRatio® 2 PT/INR Monitoring System in the short term as long as they adhere to the precautions and recommendations found in the Medical Device Correction notification of December 2014 Customer letter – December 2014) and current product insert labelling.
• Patients and healthcare providers who wish to receive an additional copy of the labelling for this product can contact Alere at 1-877-866-5313. Alere Inc. has also committed to providing instructions by email or fax to patients and healthcare providers about the return or disposal of the affected products. Alere Inc. will provide this information as soon as it is available.
• IN Ratio/IN Ratio 2 Prothrombin Time /INR Test Strips will continue to be manufactured and distributed until such time as necessary to allow patients to safely transition to another monitoring method. Users and healthcare providers can check the Alere Inc. website for updates.

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: INRatio Patient Self-Testing Monitoring System, INRatio PT Monitoring System (Professional Use) and INRatio Prothrombin Time/INR Strips (2014-12-09).

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.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

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.