The FDA classified the recall as a Class I recall — the most serious type — and said the use of these tests could cause serious health consequences or death.
The Ellume product is an antigen test that detects proteins from the SARS-CoV-2 virus from a nasal sample. The test is available without a prescription for use by people with or without COVID-19 symptoms.
The at-home test was recalled for the same reason the FDA issued an alert last month. It warned users about the potential for false-positive results of the tests due to a manufacturing issue.
A false positive shows that a person has the virus when they actually do not.
Since that Oct. 5 alert, Ellume has identified additional affected lots, bringing the total affected tests to more than 2 million.
For these tests, a false positive test result could lead to:
- Delayed diagnosis or treatment for the actual cause of the person’s illness, which could be another life-threatening disease outside of COVID-19
- Further spread of the SARS-CoV-2 virus when presumed positive people are gathered together based on false test results
- A person receiving unnecessary COVID-19 treatment — such as antiviral treatment, convalescent plasma, or monoclonal antibody treatment — which can result in side effects
- Failure to take 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, but no deaths have been reported. The reliability of negative test results is not affected.
The FDA is working with Ellume to assess the company’s corrective actions.