FDA receives more than 9,000 malfunction reports with blood testing devices
Since 2002, the FDA has received more than 9,000 reports of malfunctions with the INRatio and INRatio2 blood testing devices, the New York Times reports. The devices are used to help manage patients who are taking warfarin. The newspaper said an analysis from the Public Citizen Health Research Group found that injuries associated with the INRatio devices are far higher than similar products. However, the FDA and INRatio’s developer (INRatio) have not publicly announced the apparent malfunction.