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!