The U.S. Food and Drug Administration is aware of counterfeit at-home over-the-counter (OTC) COVID-19 diagnostic tests being distributed or used in the United States. These counterfeit tests should not be used or distributed.
Counterfeit COVID-19 tests are tests that are not authorized, cleared, or approved by the FDA for distribution or use in the United States, but are made to look like authorized tests so the users will think they are the real, FDA-authorized test. The performance of these counterfeit tests has not been adequately established and the FDA is concerned about the risk of false results when people use these unauthorized tests.
You may risk unknowingly spreading COVID-19 and may delay or stop appropriate medical treatment for COVID-19 if you use a counterfeit test.
A false-negative antigen test result means that the test says the person does not have COVID-19 but they actually do have COVID-19. A false-negative result may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause people harm including serious illness and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when people are housed together in healthcare, long-term care, and other facilities based on these false test results. When false negative test results are received, actions to limit exposure to an infected person might not be taken, such as isolating people, limiting contact with family and friends, or limiting access to places of employment.
A false-positive antigen test result means that the test says the person has COVID-19 but they actually do not have COVID-19. A false-positive result may lead to a delay in both the correct diagnosis and appropriate treatment for the actual cause of a person’s illness, which could be another life-threatening disease that is not COVID-19. False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive people are housed together.
The FDA will update this page to list counterfeit at-home OTC COVID-19 diagnostic tests to alert the public, including test users, caregivers, healthcare providers, and distributors, and to provide information on how to identify counterfeit tests.
What are some signs that an at-home OTC COVID-19 diagnostic test may be counterfeit?
- Poor print quality of images or text on the outside box label for the product or in the instructions for use included in the box.
- Missing information on the outside box label for the product, such as the lot number, expiration date, or barcode or QR codes.
- Grammatical or spelling errors found in product labeling.
- Components of the kits do not match the content description (for example, missing Instructions for Use, missing or unfilled components, different number of components than listed).
- Tradename for product printed on component or box labels differ from the authorized labeling found on the FDA website: At-Home OTC COVID-19 Diagnostic Tests.
- The box label or printed instructions for use look different from the authorized labeling found on the FDA website: At-Home OTC COVID-19 Diagnostic Tests.
What products has the FDA identified as counterfeit at-home OTC COVID-19 diagnostic tests?
- Counterfeit Flowflex COVID-19 Test Kits
- Counterfeit iHealth COVID-19 Antigen Rapid Test Kits
What should I do if I have a counterfeit at-home OTC COVID-19 diagnostic test?
Do not use the counterfeit tests. Contact the distributor or store where you purchased the test to inform them that you received a counterfeit test, and also inform the manufacturer of the authorized test. The manufacturer may ask you for additional information such as photos of the packaging to further investigate the issue. After providing any requested information to the distributor and/or manufacturer, follow the manufacturer’s instructions for returning or disposing of the test.
What is the FDA doing about counterfeit at-home OTC COVID-19 diagnostic tests?
The distribution of counterfeit COVID-19 products is a threat to the public health. The FDA regularly monitors the marketing of unauthorized, unapproved, or uncleared tests, including reports of problems with test performance or results. The FDA is working with manufacturers to address this safety issue.
