FDA MedWatch - COVID-19 Direct Antigen Rapid Tests by E25Bio

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TOPIC:  COVID-19 Direct Antigen Rapid Tests by E25Bio - Class I Recall - Tests Not Authorized, Cleared, or Approved by the FDA and May Give False Results

AUDIENCE: Consumer, Health Professional 

ISSUE: 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 FDA. Labeling distributed with some of the tests also includes inaccurate claims and instructions, including a statement that misrepresents the test as FDA-authorized.

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 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 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.

For more information about this recall, click on the red button Read Recall below.

BACKGROUND: The E25Bio COVID-19 Direct Antigen Rapid Test is used to detect proteins called antigens from the SARS-CoV-2 virus in patient samples. These samples are collected in one of three ways:

• Nasal (anterior nares) swab
• Nasopharyngeal swab, which reaches deep inside the nose, reaching the back of the throat or from the middle part of the throat (pharynx)
• Oropharyngeal swab reaching just beyond the mouth into the throat

RECOMMENDATIONS:

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:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.