E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results
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.
Recalled Product (Include the following information)
- Product Names: E25Bio COVID-19 Direct Antigen Rapid Test; Trade Name: E25Bio SARS-CoV-2 Antigen Test Kit
- Product Codes and Model Numbers: See Recall Database Entry
- Distribution Dates: September 2020 to November 2021
- Devices Recalled in the U.S.: 73,300
- Date Initiated by Firm: January 27, 2022
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
Reason for Recall
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.
Who May be Affected
- Health care providers and other organizations who used the E25Bio COVID-19 Direct Antigen Rapid Test for SARS-CoV-2 screening or diagnosis.
- People who were tested for SARS-CoV-2 using the E25Bio COVID-19 Direct Antigen Rapid Test.
What to Do
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 firstname.lastname@example.org 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 form to email@example.com or firstname.lastname@example.org.
- 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 other affected parties, including:
- Test users and caregivers: Talk to your health care providers if you were tested with the E25Bio COVID-19 Direct Antigen Rapid Test and there are concerns about test results, or if you believe you may have been harmed when collecting your own nasopharyngeal and oropharyngeal swab sample.
- Health care providers: If your patient was tested with the E25Bio COVID-19 Direct Antigen Rapid Test in the last 2 weeks and you suspect an inaccurate result, consider retesting your patients using an FDA authorized SARS-CoV-2 diagnostic test. If testing was performed more than two weeks ago, and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.
- Testing program organizers: Notify participants in your testing program to stop using the E25Bio COVID-19 Direct Antigen Rapid Test and to use an FDA-authorized test.
Customers with questions or concerns about this recall may contact E25Bio at email@example.com.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices, including suspected false results or injuries from self-swabbed nasopharyngeal or oropharyngeal samples, to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.