Ellume, maker of an at-home COVID-19 test, is recalling some of its testing kits over concerns that users have an increased chance of receiving an incorrect positive result.
"The voluntary recall is being taken after specific product lots reported false-positive test result rates higher than was observed in clinical testing," the company said in its October 1 recall announcement.
The recall impacts about 195,000 unused units of the Ellume COVID-19 Home Test, the company tells Health. That means that about 5.6% of the approximately 3.5 million test kits that Ellume has shipped to the US are being recalled, the New York Times reports.
The Ellume COVID-19 Home Test, which is performed via a nasal swab, received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for people ages 2 and up back in December 2020, making it the first over-the-counter, fully at-home diagnostic test for COVID-19 to receive such an authorization. According to the company website, the test is for people with or without symptoms and is usually able to provide results that are 96% accurate in 15 minutes. The results of these recalled kits were compromised due to "variations in the quality of one of the raw materials used in the test kit," according to the Times.
While nearly 200,000 tests have been recalled, the manufacturing problem actually affected a total of about 427,000 tests. But about half of those impacted tests have already been used, Ellume Chief Executive Sean Parsons told the Times, making the kits impossible to include in the recall. Of those tests that have been used, approximately 42,000 yielded positive results, which include both true positives and false positives, according to Ellume. While as many as a quarter of those positives may have been wrong, Parsons said it's hard to know for sure how many were inaccurate.
What should I do if I have a recalled test kit?
The Ellume site includes a list of all the specific test kits that are affected by the recall, as well as a tool that lets you input your test kit's information so that you can easily determine whether yours is one that is impacted. If your kit is one that has been recalled, you will be asked to complete a form to receive a replacement test.
If you already used one of the affected kits and received a positive test result, Ellume says it will be contacting you. If that test was done within the past two weeks and you didn't do follow-up molecular testing, such as a PCR test, to confirm the positive test, the FDA recommends contacting your health care provider, urgent care facility, or other COVID-19 testing site so that you can request a COVID-19 molecular diagnostic test.
If you took a test from one of the affected lots more than two weeks ago and got a positive result, then you may be wondering whether or not you actually had the virus. In that case, it's important to speak with a health care provider about next steps. "You should not assume that you had COVID-19 or have immunity to COVID-19. You should continue to take recommended precautions, including vaccination, to avoid COVID-19 infection, following the Centers for Disease Control and Prevention's guidelines," according to the FDA.
If you already used one of the affected kits and received a negative test result, know that that result still stands true. There were about 160,000 negative test results from the affected lots, but Ellume says that "the reliability of negative results is unaffected by this issue" and aren't included in the recall.
If you have one of the affected tests and go to use it, the app will let you know that the test has been recalled.
What does this news mean for the future of at-home COVID testing?
The affected test kits were sent to retailers and distributors from April 2021 through August 2021. "Certain affected COVID-19 test kits were also supplied to the US Department of Defense to be further distributed to community health programs as part of the National Strategy for the COVID-19 Response and Pandemic Preparedness Plan," according to a press release sent to Health. Ellume is now working with the FDA to remove the affected tests from the market.
Ellume is also trying to fix the issue that led to the recall and hopes to distribute its tests again soon.
"We offer our 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," Ellume said in a statement on its site.
The news comes as the FDA granted an EUA on October 4 to another at-home COVID test: the ACON Laboratories Flowflex COVID-19 Home Test. According to the FDA, the latest authorization "should significantly increase the availability of rapid, at-home tests and is expected to double rapid at-home testing capacity in the US over the next several weeks."
In that EUA announcement, the FDA reminded people that "all tests can experience false negative and false positive results. After taking an at-home COVID test—which the FDA considers a "critical" part in the fight against COVID—"individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not rule out a COVID-19 infection."
The Centers for Disease Control and Prevention offers detailed guidance about at-home tests, saying they are a good option if you need to be tested for COVID-19 and can't get tested by a health care provider.
The information in this story is accurate as of press time. However, as the situation surrounding COVID-19 continues to evolve, it's possible that some data have changed since publication. While Health is trying to keep our stories as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the CDC, WHO, and their local public health department as resources.
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