Home Page Potential Lawsuit Alere INRatio2 PT INR Professional Test Strips Recalled Due to Patient Deaths
Alere INRatio2 PT INR Professional Test Strips Recalled Due to Patient Deaths
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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 Pushes for Dismissal of Home Blood Test Kits Class Action
Boston, MA: In response to plaintiffs' January motion to keep an Alere INRatio class action lawsuit alive, Alere recently pushed back with arguments that the court should dismiss the case [READ MORE]
Failed INRatio Device Fast-Tracked to Market
San Diego, CA: A new Alere lawsuit filed earlier this month in San Diego asserts that the allegedly failed Alere INRatio measuring device was approved through the issuance of a 510(k) Clearance by the US Food and Drug Administration (FDA). The problematic measuring system, comprised of test strips and a measuring device, were subject to an FDA-sanctioned Alere recall in 2014. Lawsuits are continuing to roll in [READ MORE]
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]
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