Inaccurate INR Results Prompt Recall of Test Strips – APhA submits compounding comments to FDA. – (866) 348-2889.
Test strips used with medical devices that monitor warfarin levels have been recalled by Roche Diagnostics, due to inaccuracies. The recall encompasses 43 lots with more than 1.1 million packages of Roche’s CoaguChek XS PT Test Strips, manufactured from January 12, 2018 to October 29, 2018.1,2
The FDA announced the action as a Class I recall. The most serious type of recall, the Class I designation means that these devices may cause serious injuries or death.1
Also known by the brand names Coumadin and Jantoven, warfarin is a blood thinner used to prevent and treat blood clots. The drug may be prescribed for individuals with certain types of irregular heartbeats, blood clots in the lungs or legs, or certain implanted medical devices, such as artificial heart valves.1