Alere INRatio2 PT INR Professional Test Strips Recalled Due to Patient Deaths

Washington, DC: Alere is recalling its INRatio2 PT/INR Professional Test Strips 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. 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. Given these reports, Alere is concerned that the AlereINRatio2 PT/INR Professional Test Strips may report an inaccurately low INR result.

Alere will transition 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.
 

Legal Help

If you or a loved one has suffered similar damages or injuries, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Last updated on Sep-3-20