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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm - FDA Safety Communication

The FDA issued a safety communication to alert people of the potential for harm if FDA-authorized at-home COVID-19 tests are not used according to the manufacturer’s test instructions. The FDA is also reminding people to keep the tests out of reach from children and pets.

The FDA has received reports of injuries caused by the incorrect use of at-home COVID-19 tests, such as people putting the test chemicals in their eyes, when the small vials of test solution were mistaken for eye drops. The FDA is also aware of children putting small plastic vials in their mouth and swallowing test solution.

This safety communication provides: 

• Recommendations for people using FDA-authorized at-home COVID-19 diagnostic tests 
• Background on the issue and the FDA’s actions  
• Instructions for reporting problems with at-home COVID-19 testing to the FDA 

Questions? 

If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE) or the customer service department for the COVID-19 test you are using.