COVID-19 home test recalled for potential false positive results

Coronavirus

Food and Drug Administration building is shown Thursday, Dec. 10, 2020 in Silver Spring, Md. A U.S. government advisory panel convened on Thursday to decide whether to endorse mass use of Pfizer’s COVID-19 vaccine to help conquer the outbreak that has killed close to 300,000 Americans. (AP Photo/Manuel Balce Ceneta)

Ellume has recalled their COVID-19 home test results because they have the potential to give false positive results for the virus, according to a release from the Food and Drug Administration.

For these tests, a false positive result shows that a person has the virus when they do not have it.

The FDA has classified the recall of the at-home tests as a Class I recall, which is the most serious type of recall.

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

For more information about the recall, click here.

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