(ABC4) – The Federal Drug Administration has issued a recall of a COVID-19 direct antigen rapid test Friday afternoon.
E25Bio is recalling its COVID-19 Direct Antigen Response Tests (DART) for several reasons, it says in a press release.
The tests were marketed and distributed to U.S. customers without FDA approval, approval or approval. Some of the test labels contain inaccurate claims and instructions, including a statement that misrepresents the test as FDA-authorized.
On February 4, 2022, the FDA issued one Security communication warn users to stop using the tests.
As the test has not been approved, approved or approved by the FDA, there is not enough data to show that the test’s performance is accurate.
This risks achieving false-positive and false-negative test results.
According to the FDA, 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 states that the person has SARS-CoV-2 virus present, but they are not actually infected.
There is also a risk of injury if users follow any labeling instructions that indicate self-collection of nasopharyngeal or oropharyngeal specimens, a press release said.
Who can be affected?
- Healthcare providers and other organizations using the E25Bio COVID-19 Direct Antigen Rapid Test for SARS-CoV-2 screening or diagnosis.
- Individuals tested for SARS-CoV-2 using the E25Bio COVID-19 Direct Antigen Rapid Test.
The FDA says only trained health care providers should collect these types of inoculation samples to prevent serious injury.
At present, there have been no reports of injuries, adverse health consequences or deaths associated with the use of the recalled tests.