Blood Clot Test Strips Voluntarily Recalled Following Three Deaths

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Alere Inc. has voluntarily recalled Alere INRatio2 PT/INR Professional Test Strips after nine adverse events — including three deaths — were linked to the defective medical device.

The prothrombin time test measures how long it takes for a patient’s blood plasma to clot. The results are given as an international normalized ratio. Medical providers typically perform the test on patients who are taking the blood-thinning medication Warfarin for the following purposes:

  • Monitor the patient’s health and reaction to the blood thinners

  • Determine the cause of abnormal bruising or bleeding

  • Assess liver function

  • Diagnose blood clots and bleeding disorders

In some patients, the test strips indicate PT results in the normal range, but much lower than the levels reached in the point of care laboratory tests. Doctors cannot accurately diagnose patients’ serious medical condition because of the initial false readings. At least nine patients suffered severe bleeding before the central lab results revealed a medical problem.

Alere Inc. has been unable to determine what caused the inconsistent test readings and so issued the voluntary Class 1 recall this May. The U.S. Food and Drug Administration defines a Class 1 recall as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

If you use the Alere INRatio2 PT/INR Professional Test Strips, the manufacturer advises:

  • Stop using Alere INRatio2 PT/INR Professional Test Strips.
  • Use a plasma-based laboratory INR test or another point-of-care monitoring system.
  • Return unused products to Alere Inc.
  • Report adverse events you experienced to the FDA's MedWatch Adverse Event Reporting program.

Ask your doctor whether you should take additional steps to protect your health and assess for medical problems.

 

Topics:  Medical Devices, Pharmaceutical, Product Recalls

Published In: Consumer Protection Updates, Products Liability Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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