FDA Update: PT/INR Testing Strips Recalled

The U.S. Food and Drug Administration (FDA) has alerted health care professionals that the Alere INRatio2 PT/INR Professional Test Strip was recalled by the manufacturer due to "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." Nine adverse event reports, including three involving bleeding associated with patient deaths, prompted the recall. "Given these reports, Alere is concerned that the AlereINRatio2 PT/INR Professional Test Strips may report an inaccurately low INR result," noted the FDA.

Impacted customers will be transitioned from the current Alere INRatio2 PT/INR Professional Test Strip to the Alere INRatio PT/INR Test Strip (PN 100139). According to the FDA, the Alere INRatio PT/INR Test Strip (PN 100071), used for home INR monitoring, is not impacted by the voluntary recall.

"Healthcare professionals should 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," recommended the FDA.


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