 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
The U.S. Food and Drug Administration (FDA) is warning people not to use the E25Bio COVID-19 Direct Antigen Rapid Test (DART). 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 (DART) 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 (DART) 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), which 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.
This safety communication provides:
- Important recommendations for people tested with the E25Bio COVID-19 Direct Antigen Rapid Test, health care providers and testing program organizers.
- Details on the issue and the FDA’s actions to address the issue.
- Instructions for reporting problems with this and any COVID-19 test to the FDA.
Questions?
If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).
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