- Check that your test is authorized by the FDA
At-Home OTC COVID-19 Diagnostic Tests
to see if your test is authorized. You can see if your test has been recalled at the FDA
Recalls, Market Withdrawals, & Safety Alerts webpage. Type “COVID test” in the Search box and look for your test in the list.
- Check for signs that the test might be 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
On 4-29-22 the FDA
advised consumers about counterfeit Flowflex COVID-19 Antigen Home Tests and iHealth COVID-19 Antigen Rapid Test Kits.
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.
If you had a problem with a COVID test, please report it to FDA’s
DO NOT USE THESE TESTS
The FDA issued notices for the following tests:
- 2-8-23: Universal Meditech, Inc., Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) Class 1 Recall FDA Recall
- 12-27-22: Empowered Diagnostics, CovClearCOVID-19 and ImmunoPass COVID-19 Neutralizing Antibody Rapid Antigen Tests FDA warning
- 12-12-22: Detect, Inc. Covid-19 Test, Lot #s: HB264, HY263, HY264
- 10-13-22: Jiangsu Well Biotech COVID-19 Ag Rapid Test Device Recall FDA Recall
- 8-2-22: North American Diagnostics Oral Rapid SARS-CoV-2 Rapid Antigen Test Kit Recall FDA Recall
- 5-17-22: Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) Class 1 Recall
- 3-17-22: SD Biosensor Inc. STANDARD Q COVID-19 Home
Ag Test Class | Recall
- 3-2-22: Celltrion DiaTrust COVID-19 Ag Rapid Test (green and white packaging).
- 3-1-22: ACON Laboratories Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) (dark blue packaging).
- 2-4-22: E25Bio COVID-19 Direct Antigen Rapid Test.
- 1-28-22: Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass
COVID-19 Neutralizing Antibody Rapid Test.
- 1-11-22: LuSys Laboratories COVID-19 Antigen Tests (may also be labeled Luscient Diagnostics, Vivera Pharmaceuticals, or EagleDx).