FDA Provides Update on E25Bio’s Recall of its COVID-19 Direct Antigen Rapid Test

The FDA has issued on update on E25 Bio’s Jan. 27 recall of its E25Bio SARS-CoV-2 antigen test kit, deeming it a Class 1 recall because of the risk of serious injury or death.

The agency noted that the antigen tests were marketed and distributed to U.S. customers without its authorization, clearance or approval and that labeling included with some of the tests inaccurately claimed they were FDA-authorized.

The FDA said that there is a risk of both false-negative and false-positive test results for users of the unauthorized tests. But there have been no reports of adverse events linked to the tests, the agency said.