Alere Initiates Voluntary URGENT CORRECTION for Use of Alere INRatio and INRatio2 PT/INR Monitor System

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Tue, 09 Dec 2014 04:58:42 -0600

Title:     Alere Initiates Voluntary URGENT CORRECTION for Use of Alere INRatio and INRatio2 PT/INR Monitor System

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Alere Initiates Voluntary URGENT CORRECTION for Use of Alere INRatio and INRatio2 PT/INR Monitor System
12/08/2014 07:39 PM EST

Alere Inc. (NYSE:ALR) has initiated a voluntary correction to inform U.S. users of the Alere INRatio and INRatio2 PT/INR Monitor system of certain medical conditions that should not be tested with the system (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips). In certain cases an INRatio and INRatio2 PT/INR Monitor system may provide an INR result that is clinically significantly lower than a result obtained using a reference INR system (laboratory method).

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