Alere Conducting Class I Recall of INRatio2 PT/INR Test Strips
Diagnostics company Alere Inc. today announced a class I recall of INRatio2 PT/INR Professional test strips (PDF) because of reports of the results differing greatly from those obtained by a central laboratory.
The company said it has received nine reports describing serious adverse events and INRatio2 PT/INR Professional results that differed from laboratory results by 3.1 to 12.2 International Normalized Ratio (INR) units.
In all nine reports, the company said, the INRatio2 PT/INR Professional result was in the therapeutic INR range or "near therapeutic" but the laboratory-determined plasma INR was "significantly higher."
Three of the reports described bleeding that was associated with patients' death, the company said.
Alere said it has advised health care professionals to immediately stop using INRatio2 PT/INR Professional test strips and return unused ones to the company.
This recall, the company said, does not apply to INRatio PT/INR test strips, which are intended for use by patients who monitor their INR at home.
According to a document at FDA's website, the Alere INRatio2 PT/INR monitoring system—which includes the test strips—is for use by health care professionals to determine the INR in fresh capillary whole blood as part of monitoring the effect of warfarin on clotting time in patients who are stabilized on the anticoagulant. Although the brand name includes the abbreviation PT, INRatio2 PT/INR test strips measure only INR. Measurement of prothrombin time is a feature of INRatio PT/INR test strips.