FDA Issues Safety Alert after Reports of Injury Related to COVID-19 Home Test Kits

Injuries have included accidental use of test solution as eyedrops and children ingesting test parts and swallowing test solution.

The US Food and Drug Administration (FDA) has issued a safety communication regarding the potential for harm if FDA authorized at-home COVID-19 tests are not used according to the manufacturer’s test instructions.

The typical elements of at-home COVID-19 are test cartridges, nasal swabs, and small plastic vials with liquid solution that may contain chemicals such as sodium azide. The incorrect use of these tests may cause harm if, for instance, the liquid solution comes in contact with the skin, nose, mouth, or eyes, or if it is swallowed.

Reports have been submitted to the FDA of injuries caused by incorrect use of at-home COVID-19 tests, including:

  • Accidental application of liquid test solution to the eyes when the small vials of the solution were mistaken for eyedrops.
  • Erroneous placement of the nasal collection swab into the test solution before swabbing the nose (there should be no contact between the body and the liquid solution).
  • Children putting parts of the test kit in their mouth and ingesting liquid test solution.

The FDA provides the following recommendations to ensure safe use of all at-home CVOID-19 tests:

  • Keep all parts of at-home COVID-19 test kits out of reach from children and pets before and after use.
  • Store the at-home COVID-19 test in its box until you are ready to use it.
  • Follow the manufacturer’s step by step test instructions exactly.
  • After you perform the test:
  • Follow all test instructions for how to throw away the used test parts.
  • Wash your hands thoroughly with soap and water.

Issues related to COVID-19 testing should be reported to the FDA’s MedWatch Voluntary Reporting program.

Consider making the following information available to all patients in your practice or clinic:

  • They can send an email to the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100. You can also recommend that patients contact the customer service department for the COVID-19 test they are using.
  • The Health Resources and Services Administration has a guide to state and county poison centers: Find a Poison Center

Reference: Use and store at-home COVID-19 tests properly to avoid potential harm: FDA safety communication. News release. US Food and Drug Administration. Accessed March 23, 2022.