On July 11, 2016, Alere announced the voluntary recall of their INRatio and INRatio2 Monitoring Systems. The INRatio and INRatio2 Monitoring Systems are handheld blood coagulation systems used to monitor patients taking Warfarin by measuring the blood clotting time in a patient using disposable test strips. According to the FDA, there have been approximately 386,703 systems produced and distributed in the U.S. Between 2013 and 2014, Alere received 18,924 complaints from consumers citing inaccurate PT/INR test results.
Following the large influx of complaints, Alere attempted to work with the Food and Drug Administration (FDA) in an effort to resolve issues with the systems, but failed to make improvements in the system’s measurement accuracy. Accurate PT/INR measurements for patients taking Warfarin are of utmost importance. If a reading is inaccurate, the patient may be led to believe they aren’t in need of medical treatment when in reality a delay in treatment puts them at risk for excessive bleeding, hemorrhagic stroke, or even death.