FDA warns against using unauthorized COVID tests from ACON, SD Biosensor, Celltrion

Nearly two full years into the COVID-19 pandemic, the FDA is still rooting out sales of unauthorized tests and so-called treatments for the coronavirus.

Latest to catch the agency’s ire are ACON Laboratories, SD Biosensor and Celltrion, the targets of a trio of safety notices issued Tuesday.

Though all three companies have received past emergency use authorizations from the FDA for other COVID diagnostics, the regulator said unauthorized tests from each company are currently in distribution as well. The agency issued notices urging consumers not to purchase or use the tests and to be retested if they’ve already used the kits and received results within the last two weeks.

In each case, the FDA noted that using an unauthorized diagnostic carries a heightened risk of receiving false results, which could in turn lead to the needless spread of the coronavirus if proper safety protocols aren’t followed. So far, no adverse events have been reported in connection to the use of any of the unauthorized tests in the U.S.

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ACON’s Flowflex COVID-19 Antigen Home Test has been a popular over-the-counter testing option in the U.S. since it received an emergency authorization last October. The Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), however, has only received European CE mark approval and is therefore not allowed to be sold in the U.S.

Despite that, in January ACON discovered sales of an “unauthorized, adulterated and misbranded counterfeit product” using the CE marked test’s name. It promptly issued a recall of those tests in the U.S. and noted that it had not been responsible for importing the test into the country.

Aside from the slight naming differences, per the FDA, the U.S. and EU versions of ACON’s tests can be differentiated by the color of their packaging—the FDA-authorized one comes in a white box, and the other in a dark blue box—and by the “CE” printed on the front of the latter kit.

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SD Biosensor offers an at-home test that was OK’d by the FDA at the beginning of this year for distribution by Roche. The subject of its safety notice, however, is the STANDARD Q COVID-19 Ag Home Test, which is packaged in a pink and white box.

The South Korean company also issued its own recall of the tests in January. Though it confirmed the kits had been illegally imported into the U.S., there were, at the time, no known sales of the tests directly to consumers.

SD Biosensor said it was conducting an investigation into who was responsible for the illegal imports. It also pledged to double down on strengthening and enforcing contract terms with distributors to cut down on any additional illegal imports.

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Rounding out the FDA’s latest crackdown on unauthorized diagnostics is the Celltrion DiaTrust COVID-19 Ag Rapid Test. Rather confusingly, it shares a name with a Celltrion test that was authorized by the FDA in September 2021 for point-of-care use.

The unauthorized version is only cleared for European sales and can be differentiated from its American twin by its green and white box, labeling stating that it’s “for the European Union only” and the lack of a reference to FDA authorization anywhere on the packaging.

This test, too, sparked a company recall, which Celltrion initiated in December. The tests are packaged in sets of 25, and the recall spans a total of about 162,000 tests that the company said were illegally distributed in the U.S.