FDA: Class I recall of E25Bio COVID-19 Direct Antigen Rapid Tests

Editor's Note

The Food and Drug Administration (FDA) on February 18 identified the recall by E25Bio (Cambridge, Massachusetts) of its COVID-19 Direct Antigen Rapid Tests as Class I, the most serious.

The tests are being recalled for several reasons, particularly because they were marketed and distributed in the US without authorization, clearance, or approval from the FDA. Also, some labeling includes inaccurate claims and instructions, including a statement that misrepresents the test as FDA-authorized.

In addition, there is a risk of injury if users follow instructions directing self-collection of nasopharyngeal or oropharyngeal samples. Only trained healthcare providers should collect these types of samples to prevent serious injury.