CoaguChek Test Strip Lawsuits

 

Physicians prescribe the blood thinner, warfarin (which is sold under the brand names Coumadin and Jantoven) to patients with cardiac diseases and other illnesses. Due to different responses to blood thinners, many doctors will direct their patients to monitor their blood clotting response.

One of these products is  CoaguChek test strips, which measure how long it takes for blood to clot. However, early in 2019, the U.S. Food and Drug Administration (the FDA) issued a Class 1 recall of some of the manufacturing lots of those strips.

The medical device attorneys at Chaffin Luhana represent individuals whose health might have been compromised as a result of their reliance on the results of the CoaguChek product. If you have suffered an adverse medical event while you were monitoring your blood with CoaguChek test strips, you may well have a valid reason to file a CoaguChek lawsuit against the product’s manufacturers or distributors.

How Are CoaguChek Strips Used?

  • The CoaguChek product comes with a small lancet that is used to extract a small blood sample from a user’s finger.
  • The blood sample is applied to a test strip, and a meter then analyzes that strip to determine how long the user’s blood will take to clot.
  • A physician can then adjust the patient’s blood thinner medication in response to the results of that test.

Why Did the FDA Recall the CoaguChek Test Product?

A comparison of the results of the CoaguChek tests, and more detailed laboratory tests revealed that the test strips were giving results that might cause a physician to reduce or to end a patient’s use of blood thinners. The results from the recalled test strips were inaccurately telling physicians that a patient’s blood was within an appropriate range and that thinners were no longer needed.

Which Test Strips Are Affected by the Recall?

In response to FDA actions, Roche Diagnostics and Terrific Care, LLC./Medex Supply have both issued recalls for certain lot numbers of the CoaguChek XS PT test strip product. Users who purchased a CoaguChek product from either of these companies should consult with their physicians or pharmacists to determine if they received products that were included in the recall. Those individuals will be eligible to receive refunds or replacements.

What Health Risks Are Associated with the Recalled CoaguChek Test Strips?

 CoaguChek users who take lower doses of blood thinners or who stop using thinners in reliance on a flawed CoaguChek test result may face serious health consequences, including:

  • blood clots and deep vein thrombosis;
  • strokes or brain bleeds;
  • heart attacks; and
  • pulmonary embolisms.

If you have any doubts or questions about your blood thinner dosage or your reliance on a CoaguChek test strip results, consult with your physician immediately before you stop using either product. Do not adjust your blood thinner dosages without first consulting with your doctor.

 Call Chaffin Luhana for information on CoaguChek Test Strip Lawsuits

Chaffin Luhana’s medical product liability lawyers represent individuals throughout the United States who have suffered serious injuries as a result of defective medical products. Please see our website or call Chaffin Luhana’s Pittsburgh offices if you or your medical care providers have used any recalled CoaguChek Test Strips.

We will review your case and help you determine if you have a cause of action against the product’s manufacturers or distributors for any adverse health events that you may have suffered.

Additional Resources:

  1. fda.gov: Roche Diagnostics Recalls CoaguChek XS PT Test Strips Due to Inaccurate INR Test Results. https://www.fda.gov/medical-devices/medical-device-recalls/roche-diagnostics-recalls-coaguchek-xs-pt-test-strips-due-inaccurate-inr-test-results
  2. fda.gov: Terrific Care, LLC./ Medex Supply Recalls Coagucheck XS PT Test Strips Used to Monitor Blood Thinner Warfarin Due to Inaccurate Test Results. https://www.fda.gov/medical-devices/medical-device-recalls/terrific-care-llc-medex-supply-recalls-coaguchek-xs-pt-test-strips-used-monitor-blood-thinner