Alere has issued two separate recalls associated with inaccurate INR readings. According to the FDA, the INRatio and INRatio2 Monitor Systems display inaccurate INR levels for some patients. The Alere INRatio may present INR readings at healthy levels when in fact the correct INR result is much higher when obtained by more-accurate traditional laboratory plasma…
The Alere INRatio PT/INR monitor system is used by patients prescribed to the anticoagulant medication (blood thinner) warfarin. It is an electronic device powered by battery or power supply which tracks the PT/INR levels in a patient’s blood. Alere recently issued a recall of its INRatio and INRatio2 monitor systems because the medical devices provide…
Prothrombin Time (PT) is a test that measures how long it takes the liquid portion of blood (plasma) to clot. PT is an important measure to diagnose unexplained bleeding, especially when a patient is taking anticoagulants (blood thinners) like warfarin. PT is measured in seconds and usually provided as an International Normalized Ratio (INR). For a healthy individual not…
Since the FDA recall in December 2014, consumers are seeking answers as to why individuals were severely injured or died after using the Alere INRatio PT/INR monitor system and test strips to track PT/INR levels. Alere has not publicly stated when it was aware that the Alere INRatio medical device was unsafe for consumer use. Investigations into injury claims by users…
During December 2014, Alere Inc. initiated a recall of its Alere INRatio® and INRatio®2 PT/INR Monitor Systems after the medical device provided falsely low INR rest results. Alere sent a letter to U.S. consumers on Dec. 8, 2014, notifying them of important information concerning their Alere INRatio (or INRatio2) Test Strips and Monitor System. Individuals use the Alere…