The U.S. Food and Drug Administration (FDA) is warning doctors and patients that certain in-office and at-home test strips used with medical devices to monitor blood levels of warfarin (Coumadin, Jantoven) may provide inaccurate results and should not be relied on to adjust blood thinner dosages. The FDA has issued a Class I recall — the most serious type — for the test strips, warning that using them could cause serious harm or death.
In November 2018, the manufacturer of CoaguChek test meter devices issued a voluntary recall on the test strips, which is ongoing. The FDA’s warning involves catalog numbers not included in the original recall because they were not labeled or authorized for sale in the United States. According to the FDA, these products were purchased by an unknown source, imported, and sold in the U.S.
Monitoring blood levels of warfarin is critical for people taking the blood thinner, which is used to prevent and treat blood clots in millions of Americans with certain types of arrhythmias (irregular heartbeats), blood clots in the legs or lungs, or implanted medical devices like artificial heart valves. Blood levels should be monitored with a laboratory blood test or a meter device that doesn’t use test strips involved in this recall.
Sourced from: FDA