Tuesday, October 5, 2021

Ellume issues voluntary recall of specific lots of Ellume COVID-19 Home Tests

As a bit of a public service, I thought I'd post this info today.  I receive regular updates from the CDC (Centers for Disease Control) and occasionally, things come via that route that I feel deserve a blog post.  Today's is about a home test for Covid-19.  The company has issued a voluntary recall and there is the possibility consumers may have affected products in their medicine cabinets.

If you happen to have one of these kits, follow this link to find out whether your product is part of the affected lots.  It will also provide instructions on how to proceed. 

Recall Notice

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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