E25Bio is recalling its COVID-19 Direct Antigen Response Tests (DART) after it was discovered they were marketed and distributed to U.S. customers without authorization, clearance, or approval from the FDA.
Some of the test’s labeling also includes inaccurate claims and instructions, including a statement that misrepresents the test as FDA-authorized.
Because the tests lack FDA approval, there is not sufficient data demonstrating that their performance is accurate. This means there is a risk of both false-negative and false-positive test results. There is also a risk of injury if users follow any labeling instructions directing self-collection of nasopharyngeal or oropharyngeal samples. Only trained health care providers should collect these types of swab samples to prevent serious injury.
Use of the affected product could cause serious adverse health consequences or death. On Feb. 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.
In January 2022, E25Bio sent a letter to customers and distributors of this product asking them to take the following immediate steps:
- Do not use the COVID-19 Direct Antigen Rapid Test to diagnose or screen any individuals for COVID-19.
- Destroy the tests by placing them in the trash; alternatively, contact the company for assistance in removing these products from inventory.
- Complete and return a form enclosed with the letter to indicate the number of destroyed tests and the date in which the destruction of the tests took place. Users may email the completed forms to the company.
- If any tests were distributed to third parties for their own use or for further distribution, notify the company via the same form and include their identities as part of the response.
- The FDA’s Safety Communication offered recommendations for test users and caregivers, health care providers and testing program organizers.
Consumers and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.