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At-home COVID-19 Test Kits Recalled For False Positive Concern

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Ellume, an Australian Digital diagnostics company, has recalled specific lots of the Ellume COVID-19 Home Test, which has been granted Emergency Use Authorization or EUA from the U.S. Food and Drug Administration, citing false positive concerns.

The New York Times reported that the company has called back nearly 200,000 test kits, which represents about 5.6 percent of the around 3.5 million test kits shipped to the United States.

Ellume COVID-19 Home Test is the company's rapid, at-home COVID-19 antigen test. The affected Ellume COVID-19 Home Tests were distributed to retailers and distributors from April 2021 through August 2021.

Ellume CEO and Founder Sean Parsons said the company in recent weeks noticed an increased chance that its home tests from specific product lots may provide a false positive result.

The company initiated the recall after specific product lots reported false-positive test result rates higher than was observed in clinical testing. Ellume said it has investigated the issue, identified the root cause, implemented additional controls and decided to remove affected Ellume tests from the market.

The impacted Ellume COVID-19 Home Tests will be replaced.

Ellume said it will directly notify consumers who used an affected product before 09/17/2021 and tested positive. Consumers who did not obtain a confirmatory test at the time of the Ellume positive test result are advised that their test result could have been incorrect, and they may not have had COVID-19. These consumers are urged to take precautions to avoid COVID-19 infection including vaccination as per CDC guidelines.

The Ellume COVID-19 Home Test has not been FDA cleared or approved. It has been authorized by the FDA under an EUA for non-prescription home use, only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

The FDA earlier this week issued an EUA for the ACON Laboratories' Flowflex COVID-19 Home Test, an over-the-counter COVID-19 antigen test that can be used at home without a prescription. The approval is expected to double rapid at-home testing capacity in the U.S. over the next several weeks.

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