FDA Update February 8, 2022
With False Results and Possible Dangerous Sampling Methods, the FDA Advises Consumers to Not Use E25Bio COVID-19 Testing Kits
With all the rush to get covid tests on the market some companies always try to circumvent the FDA approval process. Here is one case where the FDA has caught up to the marketing of any unapproved test.
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.
mdi is working with many companies to understand the FDA EUA requirements and assisting companies in getting their covid test through the FDA approval process.
For more information on these concerns, please email us at: firstname.lastname@example.org and ref: E25Bio – COVID Testing Kits.