The Food and Drug Administration has recalled more than two million at-home Covid-19 tests sold across the country, including in Indiana, Illinois, and Kentucky, after it was discovered that they were reporting false-positive results for SARS-CoV-2.

According to the FDA, this is a Class I recall, making it the most serious type of recall that the FDA issues. The tests in question are the "Ellume COVID-19 Home Test" - an antigen test used to detect SARS-CoV-2 virus proteins using a nasal sample.

The test is available over the counter and without the need for a prescription and uses nasal samples taken from a mid-point, and not as deep as into the nose as those that reach the throat for a sample like those administered by healthcare professionals.

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Certain lots of the Ellume At-Home tests are being recalled due to "a higher-than-acceptable false positive test results for SARS-CoV-2." They do say that the reliability of the negative test results is unaffected and that a false-positive test would indicate that a person was infected with the Covid-19 virus when they are not. The FDA says that a false-positive could result in:

  • 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.

If you are in possession of one of these tests it is advised that retailers should stop all sales of the product and remove all affected products from store shelves. If you believe you may have self-administered one of these at-home tests, you can learn more about the recall, including what you should do, by visiting FDA.gov.

[Source: FDA.gov]

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