INRatio maker Alere's financial results faltered in 2014

Alere Inc. sees gross profits plunge over $100 million in 2014 In its March 2015 10k filing with the Securities and Exchange Commission (SEC), Alere, the maker of the INRatio PT/INR monitor system, revealed its gross profits in 2014 decreased $100.5 million compared to the previous year.  The dive in annual gross profits represents an 8%…

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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…

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Alere lobbied Medicare aggressively to expand the market for its INRatio PT/INR monitor system The Alere INRatio PT/INR monitor system is a medical device used to monitor the anticoagulation effects of warfarin on a patient’s blood by tracking clotting time (PT/INR).  Physicians who demonstrate to patients how to use the INRatio, and similar devices, are…

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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What you should know about the two recalls issued by Alere in 2014 In 2014, Alere San Diego, Inc. (a wholly owned subsidiary of medical device maker Alere) issued a pair of voluntary recalls in relation to its INRatio PT/INR Monitor System and Test Strips, which track a patient’s PT/INR levels while taking a blood thinning…

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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….

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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…