Alere plans to remove its INRatio and INRatio2 PT/INR monitoring system from the market and to discontinue manufacturing the product line following a Class I recall due to inaccurate test results.
The INRatio system measures blood clotting time for people taking blood thinner warfarin.
According to the Aug. 25 FDA notice, the INRatio system may generate an incorrect low result using a plasma-based INR method. If an incorrect result is acted upon, such as lowering the warfarin dose, patients could be at risk for fatal bleeding.
Alere was not able to develop an adequate modification and is thus halting manufacture of the product line, the FDA said. — Tamra Sami