FDADecember 5, 2014device
Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 The test strips are packaged in individually pouched test strips in a labeled box with 12 or 48 test strips per bo...
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
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAREF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 22922023-06-09
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