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# Xarelto Trial Analyses Finds ‘Minimal’ Impact from Faulty Devices
- URL: https://www.fdaweb.com/xarelto-trial-analyses-finds-minimal-impact-from-faulty-devices/
- Published: 2016-07-13T12:00:00.000Z
- Updated: 2026-09-14T21:14:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136175

FDA says that its analyses so far on the use of Alere’s faulty blood testing devices (INRatio and INRatio 2 PT/INR) appear to have had “minimal” impact on a clinical trial involving Johnson & Johnson’s blood thinner Xarelto. “Our analyses so far indicate that effects on strokes or bleeding, including bleeding in the head, were minimal,” FDA spokeswoman **Deborah Kotz** told the [Project on Government Oversight](http://www.pogo.org/blog/2016/07/fda-faulty-devices-had-minimal-impact.html?ref=fdaweb.com), which has been investigating the trial that was headed up by FDA commissioner **Robert Califf** when he was at the Duke Clinical Research Institute. “These effects were very unlikely to have altered our determination in 2011 that Xarelto was a safe and effective alternative to warfarin” — a generic drug in use since the 1950s — “in patients with atrial fibrillation,” Kotz said.

Alere said earlier this week ([see story](https://www.fdaweb.com/alere-yanking-inratio-devices-from-the-market/)) that it will be initiating a voluntary withdrawal of the devices 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 had been the subject of 9,469 malfunction reports and 1,445 injury reports since their original marketing in 2002.

“The FDA’s investigation on the use of Xarelto is ongoing, and we will communicate additional information as it becomes available,” Kotz said. “The FDA believes that Xarelto continues to provide an important health benefit when used as directed.”