Alere Withdraws Anticoagulation Monitoring System At Heart Of ROCKET AF Controversy

–FDA says the manufacturer has not demonstrated that it has fixed the problem. The  Alere INRatio® and INRatio®2 PT/INR Monitoring System are being pulled from the market. Alere, the manufacturer of the devices, which are used by people taking warfarin to monitor their INR, said that the action follows a “collaborative process” with the FDA. The...Click here to continue reading...

Source: CardioBrief - July 13, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Alere anticoagulation FDA INR monitoring system ROCKET-AF Source Type: blogs