Anti-Coagulation Monitoring System Recalled Due to Potential Inaccurate Measurements
In certain cases, the system may deliver a result differing from that of another measurement method
Alere is initiating a voluntary withdrawal of the Alere INRatio and INRatio 2 PT/INR Monitoring System.
In December 2014, Alere initiated a voluntary correction to inform users of the INRatio and INRatio 2 PT/INR Monitoring System that patients with certain medical conditions should not be tested with the system.
Over the course of the past two years, Alere invested in the research and development of software enhancements to address the potential, in certain cases, of the system to deliver a result that differs from that of another measurement method.
The Food and Drug Administration (FDA) has notified the company 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.
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. The company will also provide further information on patient transition to patients and healthcare providers.
Patients should speak with their healthcare providers prior to making any changes to their current PT/INR monitoring practices.
For more information, consumers can call Alere at (866) 723-2535.