July 12, 2016 — Alere Inc. is recalling a hand-held device that monitors blood-clotting rates after at least 18 deaths and thousands of reports of inaccurate readings.
The FDA has issued numerous warnings about the Alere INRatio® PT/INR devices and test strips.
The devices are used by patients on blood-thinning drugs like warfarin, which require frequent blood tests to adjust the dosage. Inaccurate readings increase the risk of severe bleeding or deadly blood clots.
The FDA said “serious adverse events” appear to be “linked to inaccurate performance,” including 18 deaths from 2014-2015. The agency asked Alere to pull the device off the market and the company voluntarily agreed.
The FDA received nearly 19,000 complaints about the INRatio Test Strips (Optimize) from 2013-2014, and issued a Class I recall in December 2014.
That same year, Alere warned that INRatio devices should not be used in patients with certain medical conditions, such as anemia.
The devices were used in a pivotal clinical trial comparing Xarelto to warfarin. The study was led by FDA Commissioner Dr. Robert Califf and concluded that Xarelto and warfarin had similar rates of bleeding. However, MedPage Today warned that erroneous readings may have skewed the study in favor of Xarelto.