US – FDA is announcing a recall for certain lots of Ellume COVID-19 Home Test Due to a Manufacturing Issue FDA Saftey Communications.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these tests may cause serious adverse health consequences or death.
Ellume is recalling certain lots of the COVID-19 Home Test because they have higher-than-acceptable false positive test results for SARS-CoV-2. The reliability of negative test results is not affected. For these tests, a false positive test result shows that a person has the virus when they do not have it and could lead to:
- Delayed diagnosis or treatment for the actual cause of the person’s illness, which could be another life-threatening disease that is not COVID-19.
- Further spread of the SARS-CoV-2 virus when presumed positive people are grouped into cohorts (that is, they are housed together) based on false test results.
- The person receiving unnecessary COVID-19 treatment from a health care provider, such as antiviral treatment, convalescent plasma, or monoclonal antibody treatment, which can result in side effects.
- 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.
There have been 35 reports of false-positive results sent to the FDA and no deaths reported.