FDA Glucose/Warfarin Test Strip Warning

The FDA Warns Against Use of Previously Owned Test Strips and Test Strips Not Authorized for Sale in the United States

The FDA is warning people who use test strips and their caregivers that test strips from a previous owner (pre-owned test strips) or test strips not authorized for sale in the United States (U.S.) should not be used because they may lead to inaccurate test results or potentially cause infection. If a user receives an inaccurate result from a test strip and uses this result as a basis for their treatment, they could take too much medication or not enough medication which could lead to serious patient injury, including death. The FDA is aware that some sellers are marketing pre-owned test strips or test strips not authorized for sale in the U.S. to consumers. These test strips may be sold through online marketplaces or directly from the seller. The FDA recommends that consumers and caregivers who use home use tests always buy unopened vials of test strips designed for their test meter through a trusted source such as their local pharmacy or through the test strip or meter manufacturer. The FDA strongly discourages you from reselling or giving away your unused test strips because this may put the buyer at risk for infection or inaccurate results.Read the FDA's Safety Communication for recommendations  about the safe use of test strips

Questions?If you have questions about this safety communication, contact the Division of Industry and Consumer Education: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ContactDivisionofIndustryandConsumerEducation/default.htm?utm_campaign=Previously%20Owned%20Test%20Strips%20Safety%20Communication&utm_medium=email&utm_source=Eloqua&elqTrackId=713CBD71956A6BCA7642BFFAD5AE88A5&elq=4fd1b1b5f43944b58f24901fe070fee4&elqaid=7495&elqat=1&elqCampaignId=6153.

FDA Website: http://app.info.fda.gov/e/es?s=2027422842&e=202493&elqTrackId=78D8A052C380BCBFF284D754BEBE9730&elq=4fd1b1b5f43944b58f24901fe070fee4&elqaid=7495&elqat=1