10/04/2021: Lab Alert: Ellume Issues Voluntary Recall of Specific Lots of Ellume COVID-19 Home Tests

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Alert

On October 1, 2021, the digital diagnostics company Ellume announced a voluntary recall on specific lots of the Ellume COVID-19 Home Test, the company’s rapid, self-administered COVID-19 antigen test, because there is an increased chance that tests from the affected lot numbers may give a false positive result.

Ellume advises consumers to visit their website to check whether their product is part of the affected lots and, if affected, to receive further instructions.

The voluntary recall is being taken after specific product lots reported false positive test result rates higher than was observed in clinical testing. Ellume has investigated the issue, identified the root cause, implemented additional controls, and is working on resolving the issue that led to this recall. Information relating to the action to be taken by distributors and retailers for the affected lots is also provided on the company’s website.

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The Laboratory Outreach Communication System

Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)

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Page last reviewed: October 4, 2021