Over 2 million Ellume COVID-19 Home Tests recalled due to false positive test results, FDA says

So far, the FDA has received 35 reports of false positive test results

Pictured is an Ellume COVID-19 Home Test. (KSAT/FDA)

If you recently used an Ellume COVID-19 Home Test and received a positive test result, it could be false. That’s why the U.S. Food and Drug Administration just issued a recall.

According to a news release from the FDA, over 2 million Ellume at-home test kits are being pulled from the shelves due to “higher-than-acceptable” false-positive test results linked to a manufacturing defect. The company first announced the defect in early October of this year.

The FDA says it is labeling this as a Class 1 recall, which is “the most serious type of recall” due to possible “serious adverse health consequences or death” if the use of these tests is continued.

The defective tests were distributed between April 13 to Aug. 26. So far, there have been 35 reports of false-positive test results, and no deaths reported, the FDA says.

The at-home nasal swab tests can be purchased over-the-counter at a pharmacy or grocery store.

Since the recall, Ellume’s CEO Dr. Sean Parsons has issued a statement on the company’s website, apologizing to customers who received a false-positive test result. It can be read below:

“In recent weeks, we noted an increased chance that Ellume COVID-19 Home Tests from specific product lots may provide an incorrect positive result. Following a thorough investigation, we isolated the cause and confirmed that this incidence of false positives is limited to specific lots.

In response, we worked with the Food and Drug Administration (FDA) to voluntarily remove affected Ellume tests from the market. Importantly, the reliability of negative results is unaffected by this issue. More information on this voluntary recall may be found here.

At Ellume, we understand that trust is central to fulfilling our purpose as a company, and we recognize that this incident may have shaken the confidence of some of those who trusted Ellume to help them manage their health and to take back a bit of control of their lives during this pandemic. To those individuals, I offer my sincere apologies – and the apologies of our entire company – for any stress or difficulties they may have experienced because of a false positive result.

You have my personal commitment that we have learned from this experience, we have implemented additional controls to ensure our product meets our high quality standards and we are going to do everything in our power to regain your trust.

At Ellume, we remain absolutely committed to developing high-quality digital diagnostics that can be relied on in a health crisis. Patient well-being and product quality are our first priorities throughout every step of the manufacturing and supply chain process. We understand you are counting on us to do nothing less.”

If you purchased an Ellume at-home COVID-19 test and want to see if it’s affected by the recall, click here.

FDA officials said if you have received a positive test result from one of the Ellume tests, you should visit a health care provider to see what further steps you should take.

You can learn more about the recall here.

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About the Author:

Cody King is a digital journalist for KSAT 12. She previously worked for WICS/WRSP 20 in Springfield, Illinois.