According to its website, Alere is issuing a voluntary recall of the Alere INRatio® PT/INR Monitor system. Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution to allow them to continue anti-coagulation monitoring in the least disruptive manner possible. In certain cases an Alere INRatio® PT/INR Monitor system may provide an INR result that is clinically significantly lower than a result obtained in a laboratory. This PT/INR system is used to monitor warfarin.
This recall comes after two years of research since December 2014 when they initiated a voluntary correction to inform users of the Alere INRatio and INRatio2 PT/INR Monitoring System that patients with certain medical conditions should not be tested with the system. Although they have attempted software modifications, the FDA notified Alere stating 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 INRatio device from the market.
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