Ellume has officially issued a recall on more than 2 million COVID-19 at-home tests 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. The tests are available for purchase without a prescription for use by people with COVID-19 symptoms.
The FDA says specific lots of the tests are being recalled because they provide a “higher-than-acceptable” false-positive results for the coronavirus. The FDA did say 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:
- Further spread of the coronavirus when presumed positive people are grouped together based on false test results
- 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
- The person receiving unnecessary COVID-19 treatment from a health care provider
- Isolation, including monitoring household or close contacts for symptoms, limiting contact with family or friends, and missing school or work
The FDA reported there have been 35 reports of false-positive results sent to the FDA with no deaths reported.
For those who have purchased this brand of at-home tests, look 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 provides a list of 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 [email protected]