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05/06/2014 03:34 PM EDT
WALTHAM, Mass. – Alere Inc. (NYSE:ALR) has initiated a voluntary Class 1 recall in the U.S. of the Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2). This action is a result of complaints of patients who had a therapeutic or near therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.