On Wednesday, November 10, the Food and Drug Administration (FDA) issued a recall of over two million Ellume at-home COVID-19 tests due to "higher-than-acceptable false positive test results," according to a statement on their website.
The defective tests were manufactured by Ellume between February 2021 and August 2021. So far, the FDA has received 35 reports of false positives-or results that say a person has COVID-19 when they do not-from these tests. Negative results were not affected by this issue.
This comes about a month after Ellume, an Australian biotech company, voluntarily recalled about 195,000 of its testing kits over the same concerns.
"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 FDA designated the recall as a Class I, or the most "serious type" since use of the tests may cause serious adverse health consequences such as delaying diagnoses or treatment for the illness actually responsible for the symptoms, causing someone to unnecessarily miss school or work, and/or receiving unneeded COVID-19 treatment.
"The Ellume team offers its sincere apologies for the stress or difficulties people may have experienced due to a false positive result," a company spokesperson tells Health. "We have and will continue to work diligently to ensure test accuracy, in all cases."
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.
According to the FDA, customers with an Ellume Covid-19 Home Test can determine whether or not it has been a part of the recall by locating the product lot number on the side of the product and comparing it to the recalled lot numbers listed in the Medical Device Recall Database Entry.
If your test kit has been recalled, do not use it, and complete a form on Ellume's website to receive a replacement. You may also report the issue to the FDA via their MedWatch program.
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. 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.
Ellume is now working with the FDA to remove the affected tests from the market, which were sent to retailers and distributors between April and August 2021.
According to a company spokesperson, Ellume has investigated and identified the cause of the inaccurate tests and has put in place additional controls to ensure the issue is resolved. In fact, they have already started producing and shipping new product to the US.
"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 in October.
For those looking for an alternative at-home COVID-19 test, the FDA granted an EUA on October 4 to 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.