The U.S. Food and Drug Administration (FDA) is warning the public not to use the E25Bio COVID-19 Direct Antigen Rapid Test, as the test may include false labeling as to its authorization status.
The agency notes that the test has not been authorized, cleared, or approved for distribution in the U.S. Furthermore, it may have false labeling stating that it is authorized by the FDA. The test may be sold under the name E25Bio SARS-CoV-2 Antigen Test Kit.
The test is not supported by adequate data that demonstrates its accuracy, according to the FDA. It may also include use instructions that could "result in serious injury," the FDA said.
The agency has not received any reports of injury or negative health consequences caused by the assay.