Large Batch Of At-Home COVID Tests Recalled As They Report False Positives

A lot of well over two million at-home COVID-19 tests have been slammed with a recall from the Australian medical technology company Ellume in the wake of the discovery that the tests were throwing false positives at a high rate.

Defined by the FDA as class-1, this recall is “the most serious” of the types of recalls that can be issued. “Use of these tests may cause serious adverse health consequences or death,” states the FDA.

As stated by the FDA, the test “detects proteins from the SARS-CoV-2 virus from a nasal sample in people two years of age or older.” It “is available without a prescription for use by people with or without COVID-19 symptoms” and “uses an analyzer that connects with a smartphone app to show users how to perform the test and understand the test results.”

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As told to The New York Times by a spokesperson for Ellume, the overall cause of the problem has been discovered.

“Ellume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S.,” stated the spokesperson. “Importantly, not all of the positive results of the affected tests were false positives, and negative results were not affected by this issue.”

As stated in a release from NPR, “The company first informed the FDA about the defect in some lots in October. On Wednesday, the FDA said it had identified additional lots that have been affected by the manufacturing defect.”

Recently, Ellume’s chief executive, Dr. Sean Parsons, stated that the company had created new policies and procedures to ensure that the problem does not happen again.

“I’m very sorry that this has happened,” he stated. “We’re all about chasing accuracy, and to have these false positives is disappointing.”

The FDA explained the reason for the recall, stating:

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.
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