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.
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