FDA: E25bio Recalls Covid-19 Direct Antigen Rapid Tests

E25Bio recalls Covid-19 direct antigen rapid tests that are not authorized, cleared, or approved by the FDA, and may give false results, the agency said in a statement.

• The FDA has identified this as a Class I recall, the most serious type of recall
• The E25Bio Covid-19 direct antigen rapid test is used to detect proteins called antigens from the SARS-CoV-2 virus in patient samples
• Trade Name: E25Bio SARS-CoV-2
• Distribution dates: September 2020 to November 2021
• Devices recalled in the U.S.: 73,300
• Date initiated by firm: January 27, 2022

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