A COVID-19 Test Recall

By Jane Farrell

The U.S. Food and Drug Administration (FDA) is warning people not to use certain Celltrion DiaTrust COVID-19 Ag Rapid Tests, a product of Celltrion HealthCare.

People should not use the Celltrion DiaTrust COVID-19 Ag Rapid Test that is in green and white packaging. This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test.

The FDA said it has not received reports of injuries, adverse health consequences, or death associated with use of this unauthorized Celltrion DiaTrust COVID-19 Ag Rapid Test.

The agency also issued specific cautions for different groups:

Test users and caregivers: Talk to your health care provider if you think you were tested with the Celltrion DiaTrust COVID-19 Ag Rapid Test and you have concerns about your test results.

Health care providers and testing program organizers: If an antigen test was performed less than two weeks ago using the Celltrion DiaTrust COVID-19 Ag Rapid Test, consider retesting your patients using an FDA authorized SARS-CoV-2 diagnostic test if you suspect an inaccurate result. If testing was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.

Report any problems you experience with the Celltrion DiaTrust COVID-19 Ag Rapid Test to the FDA, including suspected false results. The FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Test Descriptions

The unauthorized Celltrion DiaTrust COVID-19 Ag Rapid Test uses a mid-turbinate nasal swab sample to detect proteins, called antigens, from SARS-CoV-2, the virus that causes COVID-19. This unauthorized test has the same name as an FDA authorized version of the test for point of care settings but is not the same test. The unauthorized test has a green and white box with Celltrion Healthcare identified on the outer box label.

The Celltrion DiaTrust COVID-19 Ag Home Test, from Celltrion USA, Inc., was authorized by the FDA on October 21, 2021 for home use. These tests are not affected by this Safety Communication and can continue to be used.

The Celltrion DiaTrust COVID-19 Ag Rapid Test, from Celltrion USA, Inc., was authorized by the FDA on April 16, 2021, for point-of-care use, such as in health clinics. These tests are not the subject of this Safety Communication and can continue to be used.

Please refer to the authorized labeling for the Celltrion DiaTrust COVID-19 Ag Home Test and the Celltrion DiaTrust COVID-19 Ag Rapid Test, both labeled for distribution by Celltrion USA, to confirm that the test you’re using is FDA authorized.

Risks of False Test Results

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 are 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 regularly monitors the marketing of unauthorized, unapproved, or uncleared tests, including reports of problems with test performance or results. The FDA is working with Celltrion USA, Inc., to resolve this safety issue.

A recall was issued for all unauthorized Celltrion DiaTrust COVID-19 Ag Rapid Tests that were distributed in the U.S., which includes at least 162,000 unauthorized tests.

Consumers: If you think you had a problem with a SARS-CoV-2 test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.

The FDA will continue to keep the public informed of significant new information.