The main adverse side effect associated with Alere INRatio is that certain test strips have failed to correctly read INR (International Normalized Ratio) levels. In fact, the monitoring system and test strips have been linked to at least nine reported serious injuries, as well as at least three deaths.
The monitoring systems and test strips have been recalled and have been classified by the FDA as a Class 1 Recall because the device has reported normal INR levels when the patients’ levels have been either very high or very low. Inaccurate readings have led to serious complications such as excessive bleeding problems, and even death. The INR values recorded by the professional strips were 3.1-12.2 lower than laboratory results.
If you have suffered from injuries, such as excessive bleeding, due to a misreading by Alere INRatio monitor systems you may be eligible for compensation.