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Alere INRatio2 PT INR Professional Test Strips Recalled Due to Patient Deaths


Washington, DC: Alere is recalling its INRatio2 PT/INR Professional Test Strips due to complaints of patients who had a therapeutic or near therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory. Alere has received nine serious adverse event reports, three of which described bleeding associated with patient deaths.

The reason for the adverse event reports was significantly different test results between the Alere INRatio2 PT/INR Professional Test Strip and the local laboratory plasma INR test. Given these reports, Alere is concerned that the AlereINRatio2 PT/INR Professional Test Strips may report an inaccurately low INR result.

Alere will transition customers from the current Alere INRatio2 PT/INR Professional Test Strip to the Alere INRatio PT/INR Test Strip (PN 100139). The voluntary recall does not include the Alere INRatio PT/INR Test Strip (PN 100071), which is utilized by patient self-testers for home INR monitoring.

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ALERE INRATIO LEGAL ARTICLES AND INTERVIEWS

Alere INRatio Plaintiffs Petition Court to Keep Lawsuit Alive
Alere INRatio Plaintiffs Petition Court to Keep Lawsuit Alive Boston, MA: The INRatio measuring system manufactured by Alere Inc. (Alere) and subject to an Alere recall last year, has oft been highlighted as part of a study focused on the effectiveness of a new-generation blood thinner when compared against warfarin. The oft-made allegation is that inaccurate readings may have given the newer anticoagulant, in this case Xarelto, an unfair advantage over Coumadin (warfarin). The US Food and Drug Administration (FDA) has since opined that in its view, the variances in readings were not drastic enough to sufficiently skew the results [READ MORE]

INRatio Class Action Headed for Trial
INRatio Class Action Headed for Trial Los Angeles, CA The Alere INRatio home monitoring system offered warfarin (Coumadin) users a convenient way to test their blood clotting rate without having to go the doctor’s office or a laboratory. Instead, they got an expensive, unreliable and potentially dangerous product [READ MORE]

Adverse Events for Patients Using Alere INRatio System
Adverse Events for Patients Using Alere INRatio System Houston, TX: Patients taking blood thinning medications know they have to be careful to ensure their blood remains in therapeutic levels, to prevent major bleeding episodes. That’s why they use devices like the Alere INRatio2 system, to ensure that if they need it, their blood clots properly. But what happens if they can't be sure the systems that are meant to ensure their safety are actually working properly? That's the issue that was faced by some patients who use the Alere InRatio system, after the system was recalled due to concerns regarding inaccurate results [READ MORE]



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