Blood Clot Monitoring System Recalled
Following the large influx of complaints, Alere attempted to work with the Food and Drug Administration (FDA) in an effort to resolve issues with the systems, but failed to make improvements in the system’s measurement accuracy. Accurate PT/INR measurements for patients taking Warfarin are of utmost importance. If a reading is inaccurate, the patient may be led to believe they aren’t in need of medical treatment when in reality a delay in treatment puts them at risk for excessive bleeding, hemorrhagic stroke, or even death.