FDA Warns Against Use of Preowned or Unauthorized Test Strips
MONDAY, April 8, 2019 -- The U.S. Food and Drug Administration is warning patients not to use preowned test strips or test strips not authorized for sale in the United States because of possible infection or inaccurate results that could cause serious harm.
The agency says it is aware of the marketing of test strips, often used to measure warfarin International Normalized Ratio or blood glucose, that have been previously owned by another user or are not authorized for sale in the United States. They are often sold on websites such as Amazon, eBay, and Craigslist or may be sold directly from a seller. These test strips may be expired or may have been stored improperly, which could lead to inaccuracy. The agency says they could also have small amounts of blood on them from the previous owner, which could put users at risk for infection from cross-contamination. The FDA is not currently aware of any deaths or serious injuries related specifically to preowned or unauthorized test strips.
The FDA recommends inspecting packages to check if they have been opened or altered and to check expiration dates. If a user is able to purchase prescription-only test strips without providing a prescription, it is a red flag that they are not authorized for sale in the United States and should therefore not be used. Test strips should only be purchased from a trusted source such as a local pharmacy or the test strip manufacturer. Patients should consult a health care provider or pharmacist if they are unsure of where to purchase unused test strips or if they cannot afford them. Patient assistance programs are sometimes available through manufacturers or consumer advocacy organizations.
"Today's warning is part of our ongoing public health commitment to communicate when we become aware of issues stemming from the use, or misuse, of medical devices," Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA Center for Devices and Radiological Health, said in a statement. "In alerting the public and helping them to recognize the illegal sale of these products, we hope to prevent unnecessary harm to people who rely on testing."
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Posted: April 2019
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