Medical Device Safety and Recalls: Alere INRatio2 PT/INR Professional Test Strips - Results Disagree with the Confirmed PT/INR Reference Test Results Performed by Central Laboratory

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Alere INRatio2 PT/INR Professional Test Strips - Results Disagree with the Confirmed PT/INR Reference Test Results Performed by Central Laboratory

The U.S. Food and Drug Administration has issued a recall for Alere INRatio2 PT/INR Professional Test Strips.  Alere San Diego received 9 reports of malfunctions; 6 injuries and 3 three deaths caused by bleeding. The firm is recalling the Alere INRatio2 PT/INR Professional Test Strips due to complaints of patients who had a therapeutic or near-therapeutic INR result with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR result (outside of therapeutic range) when re-testing was performed by a central laboratory because of deterioration in the patient’s clinical condition.  Use of this affected product may cause serious adverse health consequences, including death.  For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm397509.htm

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