Don’t use this COVID rapid antigen test, FDA warns. It could cause inaccurate results
“Destroy” E25Bio’s COVID-19 rapid antigen tests that shouldn’t be used by consumers, the Food and Drug Administration says.
The FDA says there’s a “Class I recall, the most serious type” for the tests after they were recalled by the Massachusetts-based company “for several reasons.”
Don’t use the E25Bio COVID-19 Direct Antigen Rapid Test, also sold as a SARS-CoV-2 Antigen Test Kit, because they’re not FDA authorized or approved despite being marketed and distributed to customers as such, the agency said in a medical device recall alert on Feb. 18. The FDA first warned about the tests on Feb. 4.
“Destroy the tests by placing them in the trash.”
The company’s tests — meant to detect virus antigens to quickly notify a person if they’re COVID-19 positive or negative — collects samples through a nasal swab, a deeper “nasopharyngeal swab” that reaches the throat, or an oral swab, according to the FDA.
Some of the tests’ labeling has “inaccurate claims and instructions,” and since they’re not FDA authorized, there’s a risk of inaccurate test results. This means it could show you’re COVID-19 negative when you’re actually infected and vice versa.
There’s “a risk of injury if users follow any labeling instructions directing self-collection” of the deep nasal or oral samples that should be done only by a health care provider “to prevent serious injury,” the agency added.
The FDA notes that there have been no reported injuries of death connected to the tests as of Feb. 18.
If you or someone you know have used the recalled tests, the agency suggests raising concerns with a health care provider.
The FDA advises reporting issues with using any COVID-19 test.
E25Bio mailed letters to customers and test distributors in January with instructions on throwing away its recalled tests.
The company says to “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.”
Then it can be emailed to info@e25bio.com or recall@e25bio.com.
Antigen diagnostic tests that are FDA authorized for emergency use can be viewed here.
This story was originally published February 18, 2022 at 12:02 PM with the headline "Don’t use this COVID rapid antigen test, FDA warns. It could cause inaccurate results."
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