Alere San Diego, Inc.: Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.; Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿

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Sources: FDA iRES · Raw API Response

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