Alere’s recalled INRatio monitor system promised easy and convenient home PT/INR monitoring
In December 2014, the Food and Drug Administration issued a Class I recall for the Alere INRatio and INRatio2 monitor system and test strips. Alere admitted to receiving almost 19,000 complaints of malfunction with its INRatio monitor system and test strips, which are linked to six serious injuries and three deaths. Users report they received erroneously…