FDA – May 6, 2014 – 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.
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 Alere INRatio2 PT/INR Professional Test Strip results were between 3.1 – 12.2 INR units lower than the laboratory result. Patients may be at risk for spontaneous bleeding.
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. Given these reports, Alere is concerned that the Alere INRatio2 PT/INR Professional Test Strips may report an inaccurately low INR result. Therefore, Alere has notified customers of the discrepant results and has advised them to immediately STOP using the Alere INRatio2 PT/INR Professional Test Strips and use an alternative method to perform PT/INR testing, such as a plasma-based laboratory INR test, an alternative Alere product, or an alternative point-of-care monitoring system from a different manufacturer. Alere has requested that customers return unused product to the company.