Counterfeit At-Home OTC COVID-19 Diagnostic Tests

Provision Consulting Group
May 2, 2022
3 min read

May 02 2022

The FDA 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 health care, 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.

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 | FDA.
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 | FDA.

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.

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

For more information on the OTC medical devices for device manufacturers,

see: FDA, OTC Medical Devices Q&A for Device Manufacturers.

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