SAN FRANCISCO, Calif. (KRON) — Ellume is recalling its at-home COVID-19 test due to the potential of false positive results, the U.S. Food and Drug Administration said.

The FDA classified the recall as a Class I recall — the most serious type of recall, and says use of these tests may cause serious health consequences or death.

The at-home test was recalled for the potential for false positive results due to a manufacturing issue.

A false positive results shows that a person has the virus when they don’t actually have it.

Since then, Ellume has identified additional affected lots and the total of affected tests is now more than 2 million.

For these tests, a false positive test result shows that a person has the virus when they do not have it and could lead to:

  • 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 SARS-CoV-2 virus when presumed positive people are grouped into cohorts (that is, they are housed together) based on false test results
  • The person receiving unnecessary COVID-19 treatment from a health care provider, such as antiviral treatment, convalescent plasma, or monoclonal antibody treatment, which can result in side effects
  • Disregard for the recommended precautions against COVID-19, including vaccination
  • Isolation, including monitoring household or close contacts for symptoms, limiting contact with family or friends, and missing school or work

There have been 35 reports of false positive results sent to the FDA and no deaths reported.

The reliability of negative test results is not affected.

The FDA is working with Ellume to assess the company’s corrective actions.