E25Bio Recalls COVID-19 Tests Not Authorized by the FDA

Serious injuries or death may result from the use of these devices. This is as a Class I recall, the most serious type of recall.

If your email program has trouble displaying this email, view as a webpage. E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results  E25Bio is recalling its COVID-19 Direct Antigen Response Tests (DART) for several reasons, particularly that these tests were marketed and distributed to U.S. customers without authorization, clearance, or approval from the FDA. Labeling distributed with some of the tests also includes inaccurate claims and instructions, including a statement that misrepresents the test as FDA-authorized.   Read More The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.   Questions? If you have questions about this recall, contact E25Bio at info@e25bio.com.

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