July 12, 2016 — Alere Inc. has voluntarily recalled the INRatio PT/INR device because it can produce inaccurate readings and cause patients to take a dangerous dose of blood-thinning medications.
The hand-held device is used to measure the rate of blood-clotting. It is used by patients on blood-thinning drugs like warfarin to adjust the dosage. Inaccurate results could cause a patient to experience severe bleeding or blood clots.
At least 18 deaths have been linked to the problem, according to the Wall Street Journal.
In December 2014, the FDA issued a Class I recall for INRatio test strips after receiving nearly 19,000 complaints. The recall came after Alere warned that INRatio should not be used in patients with certain medical conditions, including anemia.
The FDA now says “serious adverse events” appear to be “linked to inaccurate performance,” and asked Alere to take the devices off the market. The company voluntarily agreed.
The problem is that the devices were used in a major clinical trial comparing Xarelto to warfarin. The study was co-chaired by FDA Commissioner Dr. Robert Califf. It concluded that Xarelto had similar rates of bleeding as warfarin, but MedPage Today says inaccurate readings may have skewed the study in favor of Xarelto.
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