The Food and Drug Administration Friday warned physicians and patients who use medical devices to monitor levels of the blood thinner warfarin that certain test strips used with the devices may provide inaccurate results and should not be relied on to adjust the drug dosage. The CoaguChek XS PT Test Strips were manufactured by Roche and distributed by Terrific Care/Medex Supply. They include catalog numbers for test strips that were excluded from a recent Roche recall because they were not labeled or authorized for sale in the U.S. However, Terrific Care/Medex Supply purchased the Roche test strips from an unknown source and imported and sold them in the U.S., FDA said. “Monitoring warfarin dosing is a critical part of using the drug properly to prevent and treat blood clots,” said FDA Commissioner Scott Gottlieb, M.D. “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.”

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