The INRatio® and INRatio®2 PT/INR Monitoring Systems (hereafter referred to as INRatio System), which include the INRatio® or INRatio2® PT/INR Monitor and the INRatio Test Strips, are handheld devices used to monitor blood clotting time as measured by PT/INR values in people taking warfarin (also known by the brand name Coumadin®). The system is intended for both health care professional and home use.
Under certain conditions, the INRatio System may generate an incorrect low result; an INR result that is lower than the result expected using a plasma-based laboratory INR method. If an incorrect low INR result is acted upon (i.e. adjusting the dose), the patient may be at risk of major or fatal bleeding. This issue can occur if the patient has certain medical conditions or if the instructions for performing the test are not followed. Alere was unable to develop an adequate modification that ensured the safety and effectiveness of the INRatio System.
For more information, please see: http://www.fda.gov/