FDA Warns Against Unauthorized Celltrion COVID-19 Tests

The FDA has issued an advisory notice warning consumers and caregivers not to use an unauthorized Celltrion DiaTrust COVID-19 Ag rapid test that is sold in green and white packaging and includes the name Celltrion Healthcare on the outer box.

The unauthorized test has the same name as an FDA-authorized version for point-of-care settings but is not the same test, the agency said. The agency authorized Celltrion USA’s DiaTrust COVID-19 Ag rapid test on April 16, 2021, for point-of-care use.

The FDA said it is concerned about the risk of false results from the unauthorized test and it urged healthcare providers to consider retesting patients who received the tests. But it has not received any reports of adverse events linked to them.