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.
Read the full article at prevention.com.