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The U.S. Food and Drug Administration (FDA) is warning people not to use the E25Bio COVID-19 Direct Antigen Rapid Test. This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and it may include false labeling representing that the test is authorized by the FDA. The E25Bio COVID-19 Direct Antigen Rapid Test may also be sold under the trade name E25Bio SARS-CoV-2 Antigen Test Kit.
The FDA is concerned about the risk of false results when using this test because E25Bio has not provided the FDA with adequate data demonstrating that the test's performance is accurate. In addition, the FDA is aware that the E25Bio COVID-19 Direct Antigen Rapid Test was sold directly to consumers and may have been accompanied by labeling with instructions for collecting a sample from deep inside the nose, reaching the back of the throat (nasopharyngeal) or from the middle part of the throat (pharynx) just beyond the mouth (oropharyngeal). Self-collecting nasopharyngeal or oropharyngeal samples for SARS-CoV-2 testing could result in serious injury when this is not done by trained professionals.
The FDA has not received reports of injuries, adverse health consequences, or death associated with use of the E25Bio COVID-19 Direct Antigen Rapid Test.
Do not use E25Bio COVID-19 Direct Antigen Rapid Test.
The E25Bio COVID-19 Direct Antigen Rapid Test uses a nasal (anterior nares), nasopharyngeal, or oropharyngeal swab sample to detect proteins called antigens from the SARS-CoV-2 virus.
The FDA has classified the recall for these tests as a Class I recall, the most serious type of recall.
The FDA regularly monitors the marketing of unauthorized, unapproved, or uncleared tests, including reports of problems with test performance or results. The FDA is providing this information to help inform test users, caregivers, health care personnel, and the public and to reduce the risk of false test results that could lead to serious illness and death.
The FDA will continue to keep the public informed of significant new information.
If you think you had a problem with a SARS-CoV-2 test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
If you have questions about this Safety Communication, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.