Over 2 Million Home COVID Tests Recalled by the FDA Due to Potential False Positives Results

Over 2 Million Home COVID Tests Recalled by the FDA Due to Potential False Positives Results
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According to a recent Food and Drug Administration (FDA) press release, the Ellume COVID-19 Home Test, which was authorized by the FDA on December 15, 2020 under an Emergency Use Authorization (EUA), with now over 2 million home tests being recalled with the FDA warning Use of these tests may cause serious adverse health consequences or death.” The Australian medical technology company Ellume first informed the FDA about the defect in its COVID-19 Home Test in October, according to an NPR report. The defective lots were manufactured by Ellume between Feb. 24, 2021 and Aug. 11, 2021 and the FDA has categorized the recall as a Class I (most serious type of recall).

The FDA issued the following reason for the recall on its website:

“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.

It’s rather ironic that Ellume’s defective lots of COVID-19 Home Tests were manufactured starting in Feb. 2021, the very month that the Biden Administration announced a $231.8 million award to Ellume USA for production of its at-home tests for the US, according to a press release on Ellume’s website. Is there something nefarious about this and how reliable are COVID-19 infection statistics after such an alarming admission?

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