Alere to Initiate Voluntary Withdrawal of the Alere INRatio and INRatio2 PT/INR Monitor System

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Tue, 12 Jul 2016 11:08:26 -0500

Title:     Alere to Initiate Voluntary Withdrawal of the Alere INRatio and INRatio2 PT/INR Monitor System

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Alere to Initiate Voluntary Withdrawal of the Alere INRatio and INRatio2 PT/INR Monitor System
07/12/2016 10:27 AM EDT

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.

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