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FDA Warns Against Using Pre-Owned Test Strips

April 10, 2019


The FDA on April 9 issued a safety communication alerting patients and health care professionals about the risks of using test strips from a previous owner or test strips not authorized for sale in the U.S. These strips may cause infection or lead to inaccurate test results, which can cause serious harm, including death, the agency said.

“Millions of Americans use test strips at home to monitor serious diseases or conditions. We recognize that some people may be choosing to purchase pre-owned or unauthorized test strips because they believe there is a cost savings. However, by doing so they may be putting themselves at risk for serious injury or even death,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “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. 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.”

The FDA is aware that some sellers are marketing test strips previously owned by another user or test strips that are not authorized for sale in the U.S. to consumers. These test strips may be sold through online marketplaces such as Amazon, eBay, and Craigslist, or directly from a seller.

Read the FDA press release.

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