Ellume Recalls COVID-19 Home Test for Potential False Positive Test Results

U.S. Food and Drug Administration sent this bulletin at 11/10/2021 10:18 AM EST

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FDA - Center for Devices and Radiological Health

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Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results

Ellume is recalling their COVID-19 Home Test because they have the potential to give false positive SARS-CoV-2 test results. For these tests, a false positive test result shows that a person has the virus when they do not have it. The recall described in this notice is for the same issue that was previously announced in the October 5, 2021, FDA Safety Communication: Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these tests may cause serious adverse health consequences or death.

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Questions?

Customers with questions about this recall should call Ellume at 1-888-807-1501 or email productsupport@ellume.com.