SAN ANGELO, TX – Two million at-home COVID-19 tests have been recalled by the FDA due to a malfunction in the kit that produces false positive results.
According to the Food and Drug Administration, Ellume has recalled certain lots of their COVID-19 Home Tests because they have higher-than-acceptable false positive test results for SARS-CoV-2. Despite the spotty 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.
Customers can find product lot numbers on the sticker on the side of the Ellume COVID-19 Home Test carton. Compare the lot number to the recalled lot numbers listed in the Medical Device Recall Database Entry. 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.
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.