Clark, Love & Hutson, PLLC

FDA recalled device used to monitor blood thinner Warfarin

On Feb. 1, 2019 the FDA announced a Class I recall for the test strip produced by Roche Diagnostics used to monitor users of the blood-thinner known as warfarin, Coumadin or Jantoven. These test strips delivered inaccurate results and could lead to serious injury or death.

Why did the FDA recall this device?

If you recently suffered a heart attack or stroke, your doctor may have prescribed a blood-thinner. They would need to be sure you were receiving the proper dosage. To do this, they may have pricked your finger and then applied it to a test strip with the brand name CoaguCheck XS PT test strips.

They inserted this test strip into a device called a CoaguCheck XS which measured how long it took your blood to clot. The device converts this information into a calculation called an International Normalized Ratio (INR). Your doctor likely prescribed your dose of blood-thinner based on this result.

Roche Diagnostics produced these test strips. Terrific Care LLC, or Medex Supply supplied them to patients in the U.S. After side-by-side lab tests, the test strips led to inaccurate INR results.

Who is in danger because of this recall?

If you bought CoaguCheck XS PT test strips through Terrific Care LLC or Medex Supply or a healthcare facility, you should have received a letter informing you of this recall. You are at an increased risk for a potentially serious cardiac event if you have one of the following:

  • A mechanical heart valve.
  • Atrial fibrillation and high-risk CHA2DS2-VASc scores.
  • A recent clotting, stroke or cardiac event.

The FDA recommends that you stop using the recalled strips immediately and return the product to an appropriate location. You may be eligible for a refund. You should also contact your health care provider and set up another way to regularly perform blood tests. These tests are essential to prevent blood clots that could be life-threatening.

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