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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

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]

Alere Inc. In Tough over Recalled INRatio, Abbott Merger in Jeopardy
Alere Inc. In Tough over Recalled INRatio, Abbott Merger in Jeopardy Georgetown, DE: An Alere lawsuit filed by former suitor Abbott Laboratories Inc. (Abbott) over a proposed merger is, for the moment, redirecting attention away from the failed INRatio measuring device that was recalled in July. The recalled product nonetheless has a role in the recent performance of Alere Inc. (Alere) that has prompted Abbott to back away. This, in spite of recent assurances from the US Food and Drug Administration (FDA) that any failings of the Alere INRatio device had no bearing on the relationship between warfarin (Coumadin) and Xarelto (rivaroxaban), and the subsequent approval of the latter [READ MORE]

Three Points for Alere INRatio Device
Three Points for Alere INRatio Device Dallas, TX: Negligence allegations against Janssen Pharmaceuticals, Johnson & Johnson and Bayer AG may have fizzled somewhat. Two recent issues do not bode well for plaintiffs filing Alere INRatio lawsuits. The FDA recently announced that the Alere INRatio anti-coagulation monitoring device had no substantial effect on the outcome of the ROCKET-AF trial and in turn did not significantly favor Xarelto as earlier suspected, and a California Alere class action suit in September was dismissed [READ MORE]



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