Alere Voluntarily Recalls PT/INR Professional Test Strips In The U.S

(RTTNews) - Alere Inc. (IMA , ALR) Tuesday announced a voluntary Class 1 recall of the Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2) in the U.S., as a result of nine serious adverse event reports, out of which three reports involved 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.

Alere said it will transition its customers from the current Alere INRatio2 PT/INR Professional Test Strip to the Alere INRatio PT/INR Test Strip (PN 100139).

The voluntary recall does not include the Alere INRatio PT/INR Test Strip (PN 100071), which is utilized by patient self-testers for home INR monitoring.

The company said that the root cause for this issue has not yet been determined; therefore it cannot determine the patient conditions or circumstances that may contribute to the discrepancy.