Alere initiates voluntary recall of the of the Alere INRatio2 PT/INR Strips Alere has initiated a voluntary Class 1 recall in the U.S. of the Alere INRatio2 PT/INR Professional Test Strips. 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. Alere has received nine serious adverse event reports, three of which described bleeding associated with patient deaths. The reason for the adverse event reports was significantly different test results between the Alere INRatio2 PT/INR Professional Test Strip and the local laboratory plasma INR test. The root cause for this issue has not yet been determined; therefore Alere cannot determine the patient conditions or circumstances that may contribute to the discrepancy.
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