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 Food and Drug Administration.
Labeling distributed with some of the tests also includes inaccurate claims and instructions, including a statement that misrepresents the test as FDA-authorized. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
As this test was not authorized, cleared, or approved by the FDA, there is not sufficient data demonstrating that the test’s performance is accurate. This means there is a risk of both false-negative and false-positive test results. False negative results are when the test does not detect the SARS-CoV-2 virus but the person is actually infected. False-positive results occur when the test says the person has SARS-CoV-2 virus present but they are actually not infected.
There is also a risk of injury if users follow any labeling instructions directing self-collection of nasopharyngeal or oropharyngeal samples. Only trained healthcare providers should collect these types of swab samples to prevent serious injury.
Use of the affected product could cause serious adverse health consequences and death. On February 4, 2022, the FDA issued a Safety Communication warning users to stop using these tests.
There have been no reports of injuries, adverse health consequences or death associated with the use of this product.
Recalled Product (Include the following information)
Product Names: E25Bio COVID-19 Direct Antigen Rapid Test; Trade Name: E25Bio SARS-CoV-2 Antigen Test Kit
Distribution Dates: September 2020 to November 2021
Devices Recalled in the U.S.: 73,300
Date Initiated by Firm: January 27, 2022
