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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

COVID-19 Home Test by Ellume: Class I Recall - Due to 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.

Today's FDA's Actions include:

• The FDA has classified the recall of the Ellume COVID-19 Home Test as a Class I recall, the most serious type of recall.
• Ellume has identified additional affected lots since our last update on October 5, 2021, and the total of affected tests is now around 2 million.
• The FDA is continuing to work with Ellume to assess the company’s corrective actions, such as additional manufacturing checks and other corrective steps, to address the reason for the manufacturing issue, and to help ensure that it is resolved and will not recur.
• The FDA will keep the public informed if significant new information becomes available.

Questions?

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