COVID-19 Home Test by Ellume: Class I Recall - Due to Potential False Positive SARS-CoV-2 Test Results

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.

Reporting Problems with Your Device

If you think you had a problem with the Ellume COVID-19 Home Test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Questions?

If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.

 

To See the Full FDA Communication Click Here