Diagnostics company Alere Inc. announced a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR blood Monitoring Systems.
Patients taking blood thinners like Coumadin, Jantoven, Warfilone (warfarin), Pradaxa (dabigatran), Xarelto (rivaoxaban), or Lovenox (enoxaparin), can to monitor their blood levels at home instead of at a lab, by using the Alere INRatio, INRatio2 PT/INR Monitor System, or INRatio Test Strips (collectively the Alere INRatio Monitoring System) to monitor their international normalized ratio (INR) while undergoing anticoagulation therapy.
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The monitor is supposed to perform a simple blood test, letting a patient and doctor doctor know if the medication is working properly or if a dose adjustment is needed.
Over the course of the past two years, Alere invested in the research and development of software enhancements to address the potential, in certain cases, of the system to deliver a result that differs from that of another measurement method.
FDA: Not effective
The FDA notified the company that it believes the company’s studies do not adequately demonstrate the effectiveness of the software modification and advised Alere to submit a proposed plan to voluntarily remove the INRatio device from the market.
Alere seeks an orderly transition for patients requiring anti-coagulation monitoring and will provide a timeline to discontinue the product line. Alere will provide further information on patient transition to patients and healthcare providers. The FDA suggest that patients speak with their healthcare providers prior to making any changes to their current PT/INR monitoring practices.
In other news, Alere Inc. was hit with a securities fraud lawsuit on April 22, accusing it of artificially inflating its share prices ahead of the Feb. 1 announcement of its proposed $5.8 billion acquisition by Abbott Laboratories Inc.
The shareholder lawsuit, filed in federal court in Boston, accused Alere of misleading investors by stating that its financial reporting followed generally accepted accounting principles. The plaintiffs, a group of individual investors, cited a federal probe into the company’s accounting for overseas sales in arguing that Alere had not adhered to those principles.