FDA warns Ellume COVID-19 at-home test has potential for false positive results

This undated photo provided by Ellume shows a self-administered rapid coronavirus at home test kit developed by Australian manufacturer Ellume. U.S. regulators on Tuesday, Dec. 15, 2020, allowed emergency use of the first rapid coronavirus test that consumers can buy without a prescription to test themselves entirely at home. (Ellume via AP) (Uncredited, Ellume)

The FDA issued a warning Tuesday the potential for false positive results with certain lots of the Ellume COVID-19 Home Test due to a recently identified manufacturing issue.

The FDA explained a “false positive” is a test result that says a person has the virus when they do not actually have it. Negative test results do not appear to be affected by the manufacturing issue. The FDA also said it is not aware of any confirmed serious injuries or deaths related to the false positive results with the affected Ellume COVID-19 Home Tests at this time.

The FDA is working with Ellume to assess Ellume’s additional manufacturing checks and other corrective steps to address the reason for the manufacturing issue and help ensure that the issue is resolved.

Read more: Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue

Related: Where are all the at-home COVID tests? At-home COVID test kits out of stock at most stores, online

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