PT/INR Monitoring Systems Being Pulled from Market
Alere has announced a voluntary withdrawal of the Alere INRatio and INRatio 2 PT/INR Monitoring System.
The Company initiated a voluntary correction in December 2014 to inform users of the INRatio and INRatio 2 PT/INR Monitoring System that patients with certain medical conditions should not be tested with these systems. The FDA was subsequently informed of the device concerns and an investigation was conducted regarding these events.
For two years, software enhancements were made to address the system's potential to deliver an INR result that was clinically significantly lower than a result obtained from a reference INR system (laboratory method). However, the FDA concluded that the submitted studies did not adequately demonstrate the efficacy of the software adjustments, and advised the Company to submit a plan to voluntarily withdraw the INRatio systems from the market.
Alere will provide guidance on transitioning patients to an alternative solution to continue anticoagulation monitoring following product discontinuation. The full list of affected products can be found here.
For more information call (866) 723-2535 or visit INR-care.com.