A major COVID-19 test recall is underway after the home test kits returned too many false-positive results due to a manufacturing error. Specifically, the voluntary COVID-19 test recall affects certain lots of Ellume COVID-19 Home Tests, which includes about 195,000 tests, The New York Times reports.
In the past few weeks, the company noticed that some of its tests were returning a higher amount of false-positive results than usual, Sean Parsons, Ellume CEO and founder, explained in a statement. That means the test gave someone a positive result for COVID-19 when they actually did not have the virus. “Following a thorough investigation, we isolated the cause and confirmed that this incidence of false positives is limited to specific lots,” Parsons continued. That discovery led the company to issue a voluntary recall on the affected lots.
Although Parsons doesn’t give many details about the underlying issue that caused the problem, the Food and Drug Administration (FDA) identifies it as a manufacturing issue—and notes that negative results do not seem to be affected in the same way. The 195,000 recalled Ellume tests, which amount for about 5.6% of the total number of Ellume home COVID-19 tests in the country, The New York Times says, were available through retailers and distributors. Some were also sent to the U.S. Department of Defense.
“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,” Parsons continued in the statement. “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.”
No matter how accurate a test is, there is always a potential for false-positive and false-negative results. Rapid tests like these have varying rates of false-positive results depending on the specific brand and whether or not the person taking the test has noticeable COVID-19 symptoms. In general, rapid tests more accurately identify positive cases when people have symptoms and when the overall prevalence of the virus is higher, according to a recent Cochrane review.
That said, there is an established protocol from the Centers for Disease Control and Prevention (CDC) for how providers and consumers should handle positive—and potentially false-positive—results from rapid tests. If someone without symptoms tests positive after using a rapid COVID-19 test, the CDC recommends they get a confirmation test with a PCR test. And if someone with symptoms tests negative, they should also confirm those results with a PCR test to be sure.
Ellume is now notifying retailers, distributors, and consumers about the recall and working with the FDA to fix the manufacturing issue. The affected tests have expiration dates between February 28, 2022, and July 31, 2022. Although the company’s statement does not say exactly where the recalled tests were sold, Ellume tests have been widely available through retailers such as Amazon, Walmart, Target, and CVS.