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CoaguChek XS PT Test Strips Linked with Serious Injuries, Death

Patients on Warfarin May Have Suffered Dangerous Blood Clots Due to Defective Home-Monitoring Test Strips

February 4, 2020

Test strips used for home monitoring of patients taking the blood thinner warfarin may have caused serious injuries or death due to inaccurate readings, leaving legal action as the only remedy for innocent patients and their families.

On Sept. 13, 2018, the U.S. Food and Drug Administration (FDA) initiated a Class I recall — the most serious type of recall — of more than 1.1 million packages of CoaguChek XS PT Test Strips manufactured by Roche Diagnostics. Although this recall was initiated in September by the FDA, the recall was not announced until Nov. 1, 2018; this recall affected CoaguChek XS test strips that were distributed nationwide from Jan. 12, 2018 to Oct. 29, 2018. The test strips were used with CoaguChek test meter devices, which use blood drawn from a finger prick to determine a patient’s International Normalized Ratio (INR) score. INR is the measurement of how much time it takes for the patient’s blood to clot.

The meters were used directly by patients as well as by some healthcare providers.

The FDA’s warning was based on medical device reports submitted by Roche Diagnostics to the agency indicating that the test strips may have provided results that were higher than the actual INR. According to Roche, the problems with the test strips arose when it recalibrated them to a new international standard. The company has since replaced the defective test strips with new test strips calibrated to the previous INR standard. Roche did not begin shipping the recalibrated test strips until Oct. 29, 2018.

What Injuries Are Associated with Roche CoaguChek XS PT Test Strips?

Inaccurate test strip readings may have resulted in some patients being prescribed an insufficient warfarin dose or having been instructed to interrupt warfarin use, putting them at increased risk for dangerous blood clots.

Blood clots can cause:

  • Death
  • Embolic stroke
  • Transient ischemic attack (commonly called “mini strokes”)
  • Pulmonary embolism
  • Arterial occlusions

What Is Warfarin Prescribed For?

Warfarin (also known by the brand names Coumadin and Jantoven) is an anticoagulant (blood thinner) that is used to prevent or treat blood clots. It may be prescribed for patients with certain types of irregular heartbeats, blood clots in the legs or lungs, or certain medical device implants such as artificial heart valves.

Patients taking warfarin require meticulous monitoring with regular blood tests, often weekly or even more frequently, to adjust their dosage to keep their blood-clotting time within a safe target range.

How Do I Know If My CoaguChek XS PT Test Strips Were Recalled?

The recall included the following test strips:

  • CoaguChek XS PT Test 2×24 Strips
  • CoaguChek XS PT Test 6 Strips
  • CoaguChek XS Test 24 Tests USA

To determine whether your CoaguChek XS PT Test Strips were included in the recall, check the lot number printed on the test strip label, which is applied to the test strip box and the test strip vial.

The following CoaguChek XS PT Test Strips lot numbers were recalled:

28124111, 28124121, 28631911, 28631921, 28631924, 28632021, 28632213, 28632312, 28632412, 29415113, 29415123, 29494221, 29494312, 29494613, 29494711, 29778721, 29779012, 29779213, 29779214, 30497213, 30497311, 30497413, 30497423, 30497515, 31404314, 31404821, 32264116, 32264212, 32264316, 32264317, 32264411, 32264421, 33045913, 33046011, 33046113, 33046312, 33046314, 33046321, 33046322, 33449612, 33449712, 33449723, 33449817

What Should I Do If I Have CoaguChek XS PT Test Strips That Were Recalled?

Patients should not to use the recalled test strips. They can use the recalibrated test strips, or in the alternative, INR testing can be performed by an accredited laboratory on blood drawn from a vein.

Patients should consult with their healthcare provider before making any changes to their warfarin dose.

What Should I Do If I Believe I (Or a Loved One) Was Injured by CoaguChek XS PT Test Strips?

Mark W. Tanner, an attorney at Feldman Shepherd who has litigated numerous cases involving defective medical devices, said that when poorly designed or inadequately tested medical devices cause injury, manufacturers must be held legally accountable.

“Regrettably, unsafe drugs and devices are still marketed to the public even after evidence of unacknowledged hazards becomes known to the manufacturer. Only the civil justice system can hold those manufacturers accountable and provide justice to those that are harmed unnecessarily by these products,” Tanner said.

Tanner recommends contacting an unsafe medical device attorney as soon as possible if you believe that you or a loved one was injured by CoaguChek XS PT Test Strips, as every state has its own strict deadlines as to when a lawsuit must be filed. If you still have the affected test strips, you should not discard them, as they are important evidence in litigation, Tanner said.


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