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Ellume recalls over 2 million COVID-19 home tests due to potential false positives

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Posted at 9:53 AM, Nov 11, 2021
and last updated 2021-11-11 13:15:51-05

DALLAS, Texas — More than 2 million COVID-19 home tests from Ellume are being recalled due to potential false-positive test results, according to the Food and Drug Administration.

The Ellume COVID-19 Home Test is an antigen test that detects proteins from the novel coronavirus from a nasal sample. It’s available without a prescription for use by people with or without COVID-19 symptoms.

The FDA says certain lots of the at-home test are being recalled because they have “higher-than-acceptable” false-positive results for the coronavirus. Though, the FDA says the reliability of negative test results is not affected.

For these tests, the FDA says a false positive test result shows that a person has the virus when they do not, which could lead to the following:

  • Delayed diagnosis or treatment for the actual cause of the person’s illness, which could be a life-threatening disease that's not COVID-19
  • Further spread of the coronavirus when presumed positive people are grouped together based on false test results
  • The person receiving unnecessary COVID-19 treatment from a health care provider
  • 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

So far, the FDA says there have been 35 reports of false-positive results sent to the FDA and no deaths reported.

Affected tests purchased by consumers but not yet used will be disabled via a software update. Ellume will also inform customers who used an affected test and received a positive result, according to the FDA.

If you purchased one of these tests, you can check to see if it’s included in the recall by looking at the product lot numbers on the sticker on the side of the carton. You can compare the lot number to the recalled lot numbers listed in the Medical Device Recall Database Entry. Ellume also has the affected lot numbers on its website.

Ellume is advising test users and caregivers to check if their products are from affected lots and if they are, they should visit this website for more instructions or they can call 1-888-807-1501 or email productsupport@ellume.com.

Ellume says test users and caregivers should also contact their health care provider, urgent care facility, or other COVID-19 testing site and request a COVID-19 molecular diagnostic test to confirm the positive test result if they used a test from one of the affected lots in the last two weeks and have not already had a follow-up molecular diagnostic test to confirm the positive test result.