FDA Warns on Use of Pre-Owned or Unauthorized Test Strips

April 8, 2019
Valerie DeBenedette

Volume 163, Issue 5

Consumers are using test strips that might lead to inaccurate results. 

The FDA has issued a safety communication about the use of pre-owned or unauthorized test strips for home use. Test strips for conditions such as diabetes or to measure warfarin levels are being sold online or directly from a seller and may yield inaccurate results. 

Although no reports of death or serious injury have been made to the FDA, the agency says that use of these strips may potentially cause infection or lead to inaccurate test results, which can cause serious harm, including death. The test strips may have expired or been stored improperly, and test strips from a previous owner may be contaminated with small amounts of blood, which could lead to infection. 

“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,” says Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. 

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The two examples of test strips the FDA noted in its communication are strips to monitor blood glucose levels and strips to monitor international normalized ratio (INR) for patients taking warfarin.

To determine if a test strip is preowned or unauthorized, the package should be checked to see if it has been opened or altered and to check expiration dates. If the seller is willing to sell prescription-only test strips without a prescription, the products may be unauthorized for sale in the United States and should not be used. Test strips should only be purchased from a trusted source, such as a local pharmacy or through the test strip manufacturer. Patients who are unsure about where to buy safe test strips or cannot afford to buy unused test strips should talk with their health care provider or pharmacist. 

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