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%…
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…
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…
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…
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…
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…
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 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…