Alere withdraws INRatio monitors from U.S. market

Alere (NYSE:ALR), in collaboration with the FDA, said today that it is voluntarily withdrawing its INRatio and INRatio 2 PT/INR monitoring systems designed to monitor blood flow and clotting. The company said it is working with the federal watchdog to “determine the most appropriate timing for product discontinuation” and said it will “provide guidance” to aid patients transitioning to alternative anti-coagulation monitoring systems in the “least disruptive way possible.” In 2014, Alere initiated a voluntary correction informing users of the INRatio systems that patients with “certain medical conditions” should not be tested with the system, and set out to improve the system through software enhancements to improve measurement accuracy. Despite developing enhancements to the system the company said it is confident addressed the issues, the FDA notified the company saying its studies did “not adequately demonstrate the effectiveness of the software modification” and asked Alere to submit a plan to remove the device from the market, the company said. Alere advised patients using the devices to speak to their healthcare providers prior to making any changes to their monitoring systems. In March, the FDA said it was considering the possible dangers from medical devices that monitor blood clotting producing false readings, according to a report from The Wall Street Journal. The FDA tracked thousands of cases of malfun...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Recalls Alere Source Type: news