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# Class 1 Recall of Alere’s INRatio Warfarin Monitor
- URL: https://www.fdaweb.com/class-1-recall-of-aleres-inratio-warfarin-monitor/
- Published: 2016-08-22T12:00:00.000Z
- Updated: 2026-09-14T21:26:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136569

FDA has classified as [Class 1 a recall ](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=148145&ref=fdaweb.com)involving Alere’s INRatio 2 PT/INR Home Monitoring System for warfarin therapy. Last month, the company said it was initiating a voluntary withdrawal of its controversial device due to concerns about inaccurate test results.

Last year, Public Citizen [reported](http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=5758&ref=fdaweb.com) that the blood testing devices, used in a [trial](http://fdaweb.com/login.php?sa=v&aid=D5134092&searchWords=califf&cate=S&stid=%241%24bn1.I0..%24Jd0gwnP4TZdk5Ltwd4HgG.&ref=fdaweb.com) of Bayer’s Xarelto overseen by a steering committee chaired by FDA commissioner **Robert Califf** when he was at the Duke Clinical Research Institute, had been the subject of 9,469 malfunction reports and 1,445 injury reports since their original marketing in 2002\. “The new data about the INRatio device’s inaccurate measurements and safety raise questions about Califf’s participation in the decision to use it in the trial, called ROCKET AF, which was started more than nine years ago and funded by Johnson & Johnson,” the advocacy group said. “False readings by the blood testing device could have skewed the trial results” in favor of Xarelto.

Alere now says that over the past two years, it invested in the research and development of software enhancements to address the potential for the system to deliver a result that differs from that of another measurement method. “Although Alere is confident that the software enhancements it developed and submitted to the FDA at the end of 2015 effectively address this issue, 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,” a company[ release](http://www.fda.gov/Safety/Recalls/ucm510746.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) said.