E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit

The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place.

On January 27, 2022, the firm began sending customers Urgent Medical Device Recall letters. Customers were instructed to do the following: Immediately examine your inventory for the affected product and quarantine any that are identified Do not use the COVID-19 Direct Antigen Rapid Test to diagnose or screen any individuals for COVID-19 Destroy the tests by placing them in the trash; alternatively, contact [email protected] for assistance in removing these products from your inventory Complete and return the response form to the firm as soon as possible, indicating the number of destroyed tests and the date in which the destruction of the tests took place; you may email the completed form to [email protected] or [email protected]. Please complete the form even if you do not have affected product on hand. If any Tests were distributed to third parties for their own use or for further distribution, please notify the firm of that information and include their identities as part of your Return Response. The enclosed form includes a section for that information to be provided. If you have any questions or concerns regarding this notice, please contact us at [email protected].