- Check that your test is authorized by the FDA
Visit
At-Home OTC COVID-19 Diagnostic Tests
(Spanish)
to see if your test is authorized.
- Check that the test is not a fake
Look at the box and materials for:
- Poor quality images or text on the label or instructions
- Missing key information, such as the lot number, expiration date, barcode or QR code (See
photos of examples
- click the name of test on the FDA webpage and scroll down to view)
- Spelling or grammatical errors
- Parts of the kit that do not match the description (for example, missing instructions, missing or empty components, different number of parts).
- Trade name, labels, or instructions that look different from the authorized labeling on the FDA website:
At-Home OTC COVID-19 Diagnostic Tests | FDA
Learn more about
counterfeit at-home COVID-19 diagnostic tests
(FDA webpage) and
how to avoid buying fake test kits online
(Federal Trade Commission) and other
COVID-19 scams and fraud.
If you think you bought a fake COVID-19 test, please report it to the Department of Consumer and Business Affairs at bit.ly/CBAHelp or 1-800 593-8222.
DO NOT USE THE FOLLOWING TESTS
Check
here to see if your test might
be counterfeit:
- 44-29-22: Flowflex COVID-19 Antigen Home Tests
- 4-29-22: iHealth COVID-19 Antigen Rapid Test Kits
Note: As of 4-29-22, the FDA is not aware of any counterfeit tests distributed by the U.S. Government test distribution programs.
Do not use these tests that are
not authorized, cleared, or approved by the FDA.
- 8-2-22: North American Diagnostics Oral Rapid SARS-CoV-2 Rapid Antigen Test Kit Recall FDA Recall
- 5-17-22: Woodside Acquisitions, Inc. Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) Class 1 Recall
FDA Recall
- 5-10-22: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) Class 1 Recall
FDA Recall
- 3-17-22: SD Biosensor Inc. STANDARD Q COVID-19 Home
Ag Test Class | Recall
FDA Recall
- 3-2-22: Celltrion DiaTrust COVID-19 Ag Rapid Test (green and white packaging).
FDA message
- 3-1-22: ACON Laboratories Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing).
FDA message
- 2-4-22: E25Bio COVID-19 Direct Antigen Rapid Test.
FDA message
- 1-28-22: Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass
COVID-19 Neutralizing Antibody Rapid Test.
FDA message
- 1-11-22: LuSys Laboratories COVID-19 Antigen Tests (may also be labeled Luscient Diagnostics, Vivera Pharmaceuticals, or EagleDx).
FDA message
For more information, visit the FDA safety
webpage.
If you are using a home-test kit, check the FDA's
website to make sure your test is authorized.
If you had a problem with a COVID test, please report it to FDA’s
MedWatch program.