Urgent Recall for Patients on Blood Thinners

Urgent Recall for Patients on Blood Thinners

Posted By Golomb & Honik, P.C. || 5-Jun-2014

If you are currently taking the anticoagulant drug warfarin (also known as Coumadin) or being given heparin injections, you may be at serious risk for developing uncontrolled bleeding. An urgent recall was issued regarding a defective brand of PT/INR test strips. In addition to patients, this recall is also important for in-office and home healthcare teams who use these monitoring systems to test their patients.

Alere Inc, recently issued an urgent recall of their INRatio2 PT/INR Professional Test Strips because of reports of the blood clot test strips reading a lower INR reading than what is truly accurate. Patients reported receiving therapeutic readings from their devices, but a central laboratory reading recorded significantly higher readings, which is critically dangerous.

The test strip in questions, PN 99008G2, monitors the blood of patients who are taking heparin or Coumadin and determines how long it takes for their blood to clot. These tests are critical to keeping patients from bleeding spontaneously or developing uncontrolled bleeding.

It has been reported that the strips are reading anywhere from 3.1 to 12.2 units lower than the accurate results, which could set patients up for spontaneous bleeding. By the time the recall was issued, the company had already received nine reports of adverse effects, including reports of three patients who bled to death.

At the moment, Alere is uncertain as to why the test strips are giving inaccurate readings. They have sent patients and healthcare professionals letters identifying the problem and the recall. They have also notified the FDA about the recall and the issue associated with the defective test strips.

Anticoagulants like Coumadin and heparin are prescribed to patients who have heart defects, suffered heart attacks, or who have undergone heart surgery. Patients with a history of pulmonary embolism or clotting disorders could also be prescribed Coumadin to reduce their risks of developing serious and life-threatening blood clots. Anticoagulants work by blocking Vitamin K and preventing the blood from clotting normally.

Bleeding disorders and heart conditions require specialized care and precise monitoring. When a defect in a medical device or in the monitoring device causes your injury or a loved one’s death, you have a right to hold the manufacturer responsible for their negligent product.

We at Golomb & Honik, P.C. can help seek justice on your behalf. Call us at (215) 278-4449 today!

Categories: Product Liability
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