FDA warns about recall of home-use test strips used with device to monitor warfarin, not authorized for sale in U.S

FDA is warning patients and health care professionals that some test strips used to monitor warfarin levels may provide inaccurate results and should not be relied upon to adjust the drug dosage. In November 2018, Roche Diagnostics recalled more than 1.1 million packages of CoaguChek XS PT Test Strips.

FDA is warning patients and health care professionals that some test strips used to monitor warfarin levels may provide inaccurate results and should not be relied upon to adjust the drug dosage. In November 2018, Roche Diagnostics recalled more than 1.1 million packages of CoaguChek XS PT Test Strips. Last month, Terrific Care/Medex Supply launched a voluntary recall of certain Roche Diagnostics test strips used with CoaguChek test meter device. FDA has classified the recall as Class I, the most serious type of recall. The test strips involved in the recall were manufactured by Roche, but distributed by Terrific Care/Medex Supply and include catalog numbers that were not included in the recent Roche recall because these strips were not labeled or authorized for sale in the United States and were only distributed by Roche Diagnostics outside the country. Terrific Care/Medex Supply purchased the Roche test strips from an unknown source and imported and sold them in the United States. FDA Commissioner Scott Gottlieb, MD, noted: "Using faulty strips can lead to errors in medication dosage that could cause serious harm or death in some patients. That's why it's so concerning that this distributor continued to sell these test strips in the U.S. even though domestic sales had been stopped due to safety concerns. To reduce risks to patients, we're warning health care providers and the public about the dangers associated with this product."