More than 2 million at-home COVID tests have been recalled due to the potential for false positive results.
The FDA issued a Class 1 recall, its most serious, saying use of the tests could cause serious health consequences or even death. The at-home test from Ellume is designed to detect antigens from a nasal sample, and is available without a prescription. It can be used by people with and without COVID-19 symptoms.
A similar manufacturing issue prompted the FDA to issue an alert on the at-home tests last month.
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.