NYSDA Publications

FDA Issues Recall of Ellume COVID-19 Home Test

The United States Food and Drug Administration (FDA) has issued a recall of the Ellume COVID-19 Home Test.  Ellume is recalling their COVID-19 Home Test because they have the potential to give false positive 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 (see NYSDA blog post from October 5, 2021).  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.  To read the FDA recall of the Ellume COVID-19 Home Test, use the link below.
https://www.fda.gov/medical-devices/medical-device-recalls/ellume-recalls-covid-19-home-test-potential-false-positive-sars-cov-2-test-results?utm_medium=email&utm_source=govdelivery
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