FDAJuly 11, 2016device
Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7 Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Test Strips. This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio¿/INRatio¿2 PT/INR System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
What to do
FDA enforcement status: Terminated
Brands named
alere san diegoalerealere san
Recall history
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