10 Medtech Recalls that Shocked the Industry—INRatio2 PT/INR Professional Test Strips

In April 2014, Alere recalled its INRatio2 PT/INR Professional Test Strips because patients reported conflicting results between the INR measurements from the INRatio2 PT/INR Professional Test Strip and a measurement from a central laboratory. These test strips are used with a monitoring system to measure the international normalized ratio (INR) levels of patients on warfarin blood thinner.

According to the FDA recall release, Alere received reports of six injuries and three deaths from bleeding.