Ellume Issues “Serious” Recall Of 2 Million Plus Home COVID Tests
The medical technology manufacturer Ellume has recalled more than 2 million at-home COVID-19 tests due to a very high number of false positives.
According to FDA.gov, this recall has been identified as a Class 1 recall which they say is "the most serious type of recall." The Food and Drug Administration states, "Use of these tests may cause serious adverse health consequences or death."
The rapid at-home antigen tests use nose swabs to detect the presence of the SARS-Cov-2 virus. So far, at least 35 false positives have been reported to the FDA. The recalled lots were manufactured between February 24 and August 11.
The Food and Drug Administration did stress that no deaths have been reported, however, false positives could lead to negative outcomes such as getting unneeded COVID-19 treatment from a health care provider or a delayed diagnosis or treatment of the actual cause of a person's illness.
The FDA also added that the reliability of negative test results is not affected. Last week the agency said in a media statement:
The FDA is continuing to work with Ellume to assess the company's corrective actions, such as additional manufacturing checks and other corrective steps, to address the reason for the manufacturing issue, and to help ensure that it is resolved and will not recur.
This is an expansion of another recall Ellume issued last month for 200,000 at-home testing kits for the same issue. Ellume was the first brand in the United States to receive FDA approval for over-the-counter COVID-19 testing.
People who bought an Ellume home COVID-19 test should check the product by entering the lot number at Ellume's website or return any recalled tests and confirm any positive results at a COVID-19 testing site.
For more information, visit the FDA's website here.