More Than 2 Million At-Home COVID-19 Tests Are Under ‘Most Serious’ Type of Recall, FDA Warns
Ellume is recalling 2.2 million of its at-home COVID-19 tests, according to a recall notice shared by the FDA.
The brand, the first to receive FDA approval for over-the-counter COVID-19 testing, previously recalled 200,000 kits due to the same issue last month.
So far, 35 false positives have been reported to the FDA; consumers are urged to return any recalled tests and confirm any positive results at a COVID-19 testing site.
If you took an at-home COVID-19 test recently, your results might have been misleading. Medical company Ellume is recalling 2.2 million of its at-home COVID-19 testing kits due to a higher-than-acceptable rate of false positives, according to an urgent recall notice shared by the U.S. Food and Drug Administration (FDA) this week.
The rapid at-home antigen tests use nose swabs to detect the presence of SARS-Cov-2 virus, and a corresponding analyzer that connects with a smartphone app to show users how to do the test and understand the test results. The recalled lots were manufactured between February 24 and August 11. A full list of recalled lot numbers and expiration dates is available on Ellume’s website.
This is an expansion of another recall the brand issued last month; at the time, 200,000 COVID-19 test kits were recalled for the same reason. So far, 35 false-positive test results—when a test incorrectly shows a positive result—have been reported to the FDA. No deaths have been linked to the recalled tests. But, according to the FDA, negative test results from these kits can be trusted.
The FDA categorizes Ellume’s recall as Class I, the most serious type. False positives can lead to a delayed diagnosis for other conditions, accidental exposure to COVID-19 from other people who actually have it, and unnecessary treatment, the agency warns, among other outcomes. Ellume was the first brand to receive FDA approval for over-the-counter COVID-19 testing in the United States.
If you used one of the affected Ellume tests and received a positive result in the past two weeks, the FDA urges you to contact your doctor or a COVID-19 testing site to confirm your diagnosis. If you received a positive test more than two weeks ago, a healthcare provider can also help you decide what to do now. “You should not assume that you had COVID-19 or have immunity to COVID-19,” the FDA warns.
Anyone who bought a recalled test should visit Ellume’s website or call 1-888-807-1501 for more information on returns and replacements.
You Might Also Like
