July 11, 2016: Alere to Initiate Withdrawal of the Faulty Blood-Thinner Monitor

Faulty Blood-Thinner Monitor

Announcement Regarding Faulty Blood-Thinner Monitor

Alere Inc. will be withdrawing from the market the blood-thinner monitor, Alere INRatio® and INRatio®2 PT/INR Monitoring System, because the device may potentially show inaccurate results.

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Blood-Thinner Monitor

This product is used to measure levels of blood-thinning medicines in the user. Blood-thinning medications are used to slow blood clotting, preventing complications like blood clots forming on artificial valves, valve obstruction and blood clots traveling to the brain and causing stroke.

In association with the U.S. Food and Drug Administration (FDA), Alere is determining when product discontinuation should occur.
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Recall of Faulty Blood-Thinner Monitor

According to the Press Release publicized by the FDA, in December 2014, Alere initiated a correction to inform users of the blood-thinner monitor that patients with certain medical conditions should not be tested with the system.

In the intervening time since this correction, Alere conducted research which they claimed had addressed the instances in which their blood-thinner monitor displayed inaccurate results due to faulty software.

The FDA, however, did not find this research to “adequately demonstrate the effectiveness of the software modification”. Due to this lack of evidence, Alere, at the recommendation of the FDA, removed the blood-thinner monitor from the market.

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The personal injury lawyers at The Weinberg Law Firm is currently assisting individuals injured by medical devices, including vaginal mesh, power morcellators, IVC filters, and endoscopes/duodenoscopes as well as other devices. Mr. Weinberg also serves as local counsel for mesh lawsuits filed against manufacturers C.R. Bard and Johnson & Johnson consolidated in New Jersey Superior Court in Bergen County.

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