Alere, Inc. is voluntarily recalling their INRatio® and INRatio®2 PT/INR Monitoring System after working with the U.S. Food and Drug Administration (FDA). In certain cases the system may provide an international normalized ratio (INR) result that is significantly lower than a result obtained using a reference INR system (laboratory method).
The device is used to track a patient’s prothrombin time (PT) and INR levels in their blood while using the prescribed blood thinner warfarin.
In December 2014, the company informed users that patients with certain medical conditions should not use the system. Since then, the company has researched software development to correct the situation. However, the FDA has notified Alere that it 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 device from the market.
