FDA issues recall for at-home COVID tests due to higher false-positive test results

ROCHESTER, N.Y. (WHEC)— Heads up if you have an Ellume at-home COVID test at your home. The Food and Drug Administration put out a bulletin saying it is recalling the tests due to what it says is a "higher-than-acceptable" false positive test result rate.

The test is an antigen test you swab in your nose.

The FDA says it’s fielded at least 35 false-positive tests. The organization says those resutls can have a number of impacts on a person including:

  • Delayed diagnosis or treatment for the actual cause of the person’s illness, which could be another life-threatening disease that is not COVID-19.
  • Further spread of the virus when presumed positive people are grouped with others.
  • A person receiving unnecessary COVID-19 treatment from a health care provider, which can result in side effects.
  • Disregard for the recommended precautions against COVID-19, including vaccination.
  • Unnecessary isolation.

The FDA says the reliability of a negative result has not been impacted.