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David Haynes, The Cochran Firm, D.C.’s managing attorney, was recently interviewed on Ring of Fire about Alere INRatio lawsuits and the FDA recall of the home PT/INR monitoring device. Ring of Fire is broadcast throughout the United States on Free Speech TV and also distributed on radio stations throughout the country. Mike Papantonio is a senior partner…

Three step process

In December 2014, the Food and Drug Administration issued a Class I recall for the Alere INRatio and INRatio2 monitor system and test strips.  Alere admitted to receiving almost 19,000 complaints of malfunction with its INRatio monitor system and test strips, which are linked to six serious injuries and three deaths.  Users report they received erroneously…

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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…

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Warfarin users put at risk by drug, INRatio monitor system The Alere INRatio PT/INR monitor system, which is currently subject to an FDA recall, was originally developed by San Jose, California-based medical device manufacturer HemoSense.  Patients taking the blood thinning drug warfarin use the INRatio monitor to measure the clotting time, known as  PT/INR levels….

FDA APPROVED Rubber Stamp cut out on white background

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…

Alere corporate history

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…

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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…

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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…