A popular at-home coronavirus test kit is being recalled because it can provide false-positive results.
The FDA says the problem affects certain lots of the Ellume COVID-19 Home Test due to a “recently identified” manufacturing issue. Negative tests do not appear to be affected by the issue, according to the FDA.
Ellume says it worked with the FDA to remove all affected Ellume tests from the market, but some of the unused test kits may still be in people’s homes.
You can find out if your test kit was affected and request a replacement at the Ellume website.
What to Do If You Used an Ellume COVID-19 Home Test
– Check if your Home Test is included in the product recall by comparing the lot number on the test carton to the lot numbers on the Ellume website.
– Contact your doctor or 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 within the last two weeks and have not had a follow-up test to confirm the positive result.
– Contact your doctor or 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 test result from a different COVID-19 test at the time of the original Ellume positive test result. A health care provider can help you determine the next steps.
If you have an unused Ellume COVID-19 Home Test from the affected lot, use the Ellume COVID-19 Home Test app or follow the directions on the Ellume website to get a replacement.