FDA Cautions Against Use of Pre-owned or Unauthorized Test Strips

PUBLISHED: Apr 8, 2019
Relevant to: All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) is warning people who use test strips and their caregivers that using test strips from a previous owner (pre-owned test strips) or test strips not authorized for sale in the United States (U.S.) may lead to inaccurate test results, potentially cause infection, and should not be used.

Incorrect results from home use tests may increase the risk of 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 such as Amazon, eBay, and Craigslist, or directly from the seller.

Pre-owned test strips may not be safe to use because:

  • The test strips may not be stored properly. For example, they may have been removed from their original packaging or not stored within the recommended temperature and humidity conditions. This could lead to inaccurate results.
  • The expiration dates might have been changed or covered up. The use of expired test strips could lead to inaccurate results.
  • The test strips may have been tampered with and could be damaged causing them to not work properly.
  • 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, potentially leading to serious patient injury, including death.
  • The test strip vials may have small amounts of blood from the previous owner on them, which can put users at risk for infection.

Test strips that are not authorized for sale in the U.S. may not be safe to use because:

  • They could be faulty or poor quality.
  • Their ability to provide an accurate result is unknown. Certain test strips require review by the FDA prior to being authorized for sale in the U.S. to provide a reasonable assurance of safety and effectiveness of the test strips when used as intended. Test strips not authorized for sale in the U.S. have not been reviewed by the FDA, and their ability to provide an accurate result is unknown.
  • 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 potentially leading to serious patient injury, including death.
  • Test strips that are not authorized for sale in the U.S. are not following FDA requirements such as FDA reporting requirements. When manufacturers don’t follow these requirements, the FDA may not become aware of product malfunctions or safety issues.

Recommendations for Health Care Providers

  • Talk to your patients about the risks of using pre-owned test strips or test strips not authorized for sale in the U.S.
  • Talk to patients or caregivers about safe and affordable options such as patient assistance programs through test strip manufacturers or other consumer advocacy organizations.

The FDA’s Safety Communication also contains specific recommendations for individuals who use test strips.

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