The Food and Drug Administration (FDA) today classified the recall of Ellume’s COVID-19 Home Test as Class I, the most serious type of recall. The agency warned that the “use of these tests may cause serious adverse health consequences or death.”
“There are ancillary risks from receiving a potentially false positive result that could cause harm, such as delaying diagnosis or treatment for the actual cause of a person’s illness that is not COVID-19,” an Ellume spokesperson wrote in an email to Verywell. “We share this concern, which is why we worked quickly to remove affected tests from store shelves and online platforms and notified impacted customers and retailers.”
The spokesperson added that the FDA did not indicate that the tests themselves caused harm, but rather the impact of the manufacturing error.
“The Ellume team offers its sincere apologies for the stress or difficulties people may have experienced due to a false-positive result. We have and will continue to work diligently to ensure test accuracy, in all cases," the spokesperson wrote.
The manufacturing issue did not appear to have affected negative results, according to the FDA. But those who received a positive result using the Ellume test kit should proceed with caution. If people did not receive a positive test from a different product at the same time, they should not assume that they’ve had COVID-19 or natural immunity from the virus, the FDA said in a statement.
Ellume worked with the FDA to voluntarily remove the affected tests from the market. The company is already producing and shipping new, unaffected test kits to the U.S., the spokesperson said.
Why Is This Error So Dangerous?
According to the FDA, receiving a false positive COVID-19 test can have serious adverse effects, like:
People could receive delayed treatment or diagnosis for another disease that they may actually have. People who don’t have COVID-19 could mingle with people who do have COVID-19, in an attempt to quarantine together, and then become infected with the virus. People could be overmedicated or unnecessarily treated for COVID-19. People could disregard COVID-19 precautions due to the assumption that they’ve had COVID-19 or natural immunity from the virus. People could unnecessarily isolate themselves and miss out on social, school, and work commitments.
What Should You Do if You Used an Ellume Test?
Anyone who purchased an Ellume test kit at least two weeks ago could be affected by the recall. Customers can check their product’s lot number against the FDA’s database. Affected tests that are not yet used will be disabled via a software update. The company will also inform customers who received a positive result.
Those who purchased a test from the affected lot, regardless of use, can request a free replacement from Ellume by filling out a form on its website. The form is complex, the company warned, as the FDA required Ellume to track and report data about the recall.
People who are now purchasing or considering purchasing an Ellume test kit should be in the clear, according to Ellume.
According to the FDA, Ellume sent all customers letters about the recall with instructions on how to handle affected products. In the letter, Ellume listed steps like removing the products from shelves, quarantining them from other products, and contacting an Ellume sales representative for further instructions.
To date, the FDA has received 35 reports of false positives and no deaths from the Ellume product.
The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.
