WALTHAM, Mass. – Following a collaborative process with the U.S. Food and Drug Administration (FDA), Alere Inc. (NYSE:ALR) will be initiating a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR Monitoring 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.
About The FDA
The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.
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