FDADecember 5, 2014device
INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio Replacement Monitor The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick refer...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions. It can also occur if the instructions in the labeling for performing the test are not followed.
What to do
FDA enforcement status: Terminated
Brands named
alere san diegoalerealere san
Recall history
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