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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

INRatio Proposed Class Action Settled Before Alere Lawsuit Could Proceed
INRatio Proposed Class Action Settled Before Alere Lawsuit Could Proceed Waltham, MA: An Alere lawsuit that had been proposed as a class action on behalf of litigants alleging injury from inaccurate readings from the INRatio blood monitoring device escaped trial when the parties involved agreed to a settlement at the eleventh hour. Briefings related to J.E. et al. v. Alere Inc. et al (Case No. 1:16-cv-11515, in the US District Court for the District of Massachusetts), and motions of dismissal put forward by Alere Inc. had been duly submitted, but the judge in the case had yet to rule on them when the settlement was announced [READ MORE]

Alere Pushes for Dismissal of Home Blood Test Kits Class Action
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
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]



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