FDA Recalls PT/INR Monitor System

The U.S. Food and Drug Administration (FDA) has issued a recall of the Alere INRatio and INRatio2 PT/INR Monitoring System after reports that patients with certain medical conditions should not be tested with the system.

According to the FDA, Alere Inc. has investigated these reports and is confident that its software enhancements have effectively addressed the issue. However, the FDA “believes the company’s studies do not adequately demonstrate the effectiveness of the software modification and advised Alere to submit a proposed plan to voluntarily remove the INRatio device from the market.”

Read the FDA’s announcement.

Clinical Topics: Anticoagulation Management, Sleep Apnea

Keywords: Anticoagulants, Device Approval, International Normalized Ratio, Mental Recall, Neuroaxonal Dystrophies, Software, United States Food and Drug Administration

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