At-home COVID-19 tests recalled after multiple false positives

At Home Covid 19 Tests Recalled After Multiple False Positives
KOAM Image/Product photo from FDA

Ellume is recalling hundreds of thousands of at-home COVID-19 tests after multiple false-positive results.

A false-positive signals that a person is infected with the virus when they are not. Negative results do not appear to be affected by the manufacturing issue.

Test maker Ellume says it’s recalling dozens of lots. They shipped to retailers like Walmart, CVS, Target and Amazon between April and August of this year.

On October 5, 2021, the FDA alerted test users about the potential for false-positive results with certain lots of Ellume COVID-19 Home Test. The FDA says these lots have a recently identified manufacturing issue.

The FDA says it’s working closely with Ellume to help resolve the issue.

A complete list of affected Ellume COVID-19 Home Tests can be found on Ellume’s websiteExternal Link Disclaimer.

FDA Recommendations for Test Users and Caregivers

  • Check if your Ellume COVID-19 Home Test is included in Ellume’s product recall by comparing the lot number on the test carton to the lot numbers on Ellume’s websiteExternal Link Disclaimer
  • Contact your health care provider, urgent care facility, or other COVID-19 testing site and request a COVID-19 molecular diagnostic test if you received a positive test result with one of the affected lots of the Ellume COVID-19 Home Test in the last two weeks and have not already had a follow-up molecular diagnostic test to confirm the positive test result
  • Contact your health care provider, urgent care facility, or other COVID-19 testing site if:
  • You received a positive test result using one of the affected lots of the Ellume COVID-19 Home Test more than two weeks ago, and
  • You did not receive a positive result from a different COVID-19 test at the time of the original Ellume positive test result
  • A health care provider can help you decide what next steps you should take
  • You should not assume that you had COVID-19 or have immunity to COVID-19
  • You should continue to take recommended precautions, including vaccination, to avoid COVID-19 infection, following the Centers for Disease Control and Prevention’s guidelines
  • If you have an unused Ellume COVID-19 Home Test from an affected lot, use the Ellume COVID-19 Home Test App or follow the directions on Ellume’s websiteExternal Link Disclaimer to request a product replacement
  • Test Description

    The Ellume COVID-19 Home Test is an antigen test that detects proteins from the SARS-CoV-2 virus from a nasal sample in people 2 years of age and older. The Ellume COVID-19 Home Test is for people with or without COVID-19 symptoms.

    Reporting Problems

    If you think you had a problem with the Ellume COVID-19 Home Test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

    Generally, as specified in a test’s EUA, device manufacturers must comply with the applicable Medical Device Reporting (MDR) regulations.