The Alere INRatio PT/INR monitor system and test strips are under Class I FDA recall The INRatio PT/INR monitor system is a medical device used to track blood clotting time (PT/INR) of patients prescribed warfarin. Warfarin is a blood thinning medication used in the prevention of clot-related conditions such as stroke and deep vein thrombosis. Patients…
FDA’s 510(k) program allows medical device makers to skip clinical trials Under a little-known FDA process, medical device makers selling products similar to previously-approved devices are able to forego the burdensome and costly traditional approval process. The FDA’s Premarket Notification program allows medical device makers like Alere to sell their products to consumers more rapidly, but critics say…
Before Alere owned the INRatio monitor, ownership of the medical device changed many hands The Alere INRatio PT/INR monitor system was developed and marketed by San Jose, California-based biotechnology firm Hemosense. HemoSense was originally named Cardiosense, Inc. when it was incorporated in March 1997, but took the name HemoSense in January 1998. The INRatio PT/INR monitor was…
Was Alere aware that the INRatio provided dangerously inaccurate INR readings for almost a decade? The International Normalization Ratio (INR) is an important measure used to monitor blood coagulation and adjust anticoagulation medications such as warfarin. If a person’s INR level is too low, he or she could be at risk of blood clots or…
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…
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…