The FDA has hit UK-based Medakit Holdings with a warning letter after finding it sold an unapproved COVID-19 serology test on its website.
The company marketed its COVID-19 Rapid Test Kit as a coronavirus serology test that could “be used anywhere,” and its box made clear it was intended for use at home.
The agency found that the product was adulterated and misbranded and ordered the firm to immediately stop selling it. The company appears to have stopped shipping to the U.S.
The agency stressed that it has not yet cleared, approved or authorized any COVID-19 serology tests for at-home testing.