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Over 2 Million At-Home COVID-19 Tests Recalled Due to False Positives


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The FDA issued a recall for over 2 million at-home COVID-19 tests developed by Australia-based Ellume USA LLC.

The Class I recall, the FDA’s most serious classification, was issued due to a concerning number of false positive test results.

There have been 35 reported false-positive results sent to the FDA, but there’s no telling the accurate number of faulty test kits.

The Ellume at-home product is an antigen test that detects proteins from COVID-19 via a nasal sample.

Individuals can take the test with or without symptoms.

But a potential manufacturing issue has led to the recall of the at-home tests.

PIX 11 highlighted the potential consequences of a false-positive test result:

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

Surprisingly, CNN ran the story:

Tests manufactured February 24 to August 11 and distributed April 13 to August 26 are included in the recall.

“The FDA is continuing to work with Ellume to assess the company’s corrective actions, such as additional manufacturing checks and other corrective steps, to address the reason for the manufacturing issue, and to help ensure that it is resolved and will not recur,” the agency said Wednesday.

Ellume is asking that affected products be removed from shelves and not sold; it advises those who have receive a positive result with one of their tests to have a follow up test to confirm their diagnosis.

In February, the Biden administration announced a $231.8 million award for Ellume USA for production of its at-home tests for the US.
But demand for home tests has remained high and supply limited. This fall, the Biden administration announced billions more dollars to help make more tests available.

In addition to the Ellume recall, I’m still waiting for a recall on the notorious PCR tests.

Let’s not forget this statement from PCR test inventor and Nobel Prize recipient Kary Mullis:

Also, let’s not forget the CDC withdrew the Emergency Use Authorization of the PCR tests due to its inability to differentiate between COVID-19 and influenza.

The Ellume at-home COVID-19 test recall is another prime example of the casedemic perpetrated on the world.

Stop submitting to these faulty tests, especially when you have zero symptoms.

Mass testing will keep us running like hamsters on a wheel to end this madness.



 

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