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.