Alere Blood Clot Test Strip Recall Issued After Warfarin Deaths

A Class I recall has been issued for blood clot test strips used during warfarin therapy monitoring, following at least nine reports of problems where the strips producing inaccurate readings, resulting in at least three deaths.  

The Alere INRatio2 PT/INR Professional Blood Clot Test Strips recall was announced on May 6, following at least nine patient injury reports involving readings that indicated significantly lower levels of warfarin clotting, causing at least three patients to suffer severe bleeding that resulted in death.

The INRatio2 PT/INR Professional Test Strips are manufactured by Alere, Inc., and used for the qualitative determination of International Normalized Ratio in fresh capillary whole blood to monitor the effects of warfarin, which is more commonly known by the brand name Coumadin.

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Warfarin is a widely used anticoagulant, which prevents the development of blood clots. However, it requires careful monitoring during treatment to maintain an adequate yet safe dose. The test strips allow patients taking the blood thinner warfarin to measure how long it takes blood to clot, preventing an overdose of warfarin that may result in life-threatening hemorrhages.

Alere announced in their recall letter that during the initial stages of the investigation they noticed the INRatio2 PT/INR Professional Test Strips may produce on average between 3.1 to 12.2 INR units lower than INR test results from a local laboratory plasma INR test, resulting in either delays in treatment or the wrong course of treatment.

Alere also announced the root cause for these issues has not been determined but they are working directly with the FDA to understand and resolve the issue.

The test strips were manufactured by Alere Inc., of Waltham, Massachusetts where they were distributed nationwide. Warfarin is a blood thinner used to prevent strokes from atrial fibrillation that has been used for decades. Its use requires careful monitoring to prevent bleeding problems.

The company recommends that customers with recalled INR test strips stop using the products immediately and switch to an alternative method to perform PT/INR testing such as a plasma-based laboratory test, and alternative Alere product, or a different point-of-care monitoring system. Customer should contact Alere at 844-292-5373 or visit them online at www.inr-care.com for instructions on how to return the unused products.

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