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Millions of at-home COVID tests recalled – Did you take one?

The COVID pandemic has been raging for more than a year and a half now. What are your chances of getting COVID? Tap or click here for a map that charts breakthrough cases.

The good news is there have been developments to help, like at-home testing kits, so you can easily find out if you’re infected. But can these tests be trusted? At-home tests don’t seem to be as reliable as expected.

That’s why millions of test kits are being recalled. It turns out that there is a strong potential for these kits to give false-positive readings. Read on to find out if you’ve taken one of the recalled tests.

Here’s the backstory

At-home COVID tests have become increasingly popular, as it is a quick way to check if you have been infected without having to go to the doctor or pharmacy. But home tests from Ellume have now been recalled for several reasons, including occurrences of false-positive results.

Ellume at-home Covid-19 tests
Credit: Ellume

The recalled Ellume COVID-19 Home Test kits were manufactured between Feb. 24, 2021, and Aug. 11, 2021, and distributed between April and August. Over 2 million of the test kits are defective, and the Food and Drug Administration (FDA) explained it had “higher-than-acceptable false-positive test results for SARS-CoV-2.”

The reasons for the recall are:

  • Delayed diagnosis or treatment for the actual cause of the person’s illness, which could be another life-threatening disease that is not COVID-19.
  • Further spread of the SARS-CoV-2 virus when presumed positive people are housed together.
  • The person receiving unnecessary COVID-19 treatment from a health care provider, which can result in side effects.
  • Disregard for the recommended precautions against COVID-19, including vaccination.
  • Isolation, including monitoring household or close contacts for symptoms, limiting contact with family or friends, and missing school or work.

The FDA said that while no deaths have been reported, there have been 35 cases of false positives.

What you can do about it

This isn’t the first time that Ellume has had at-home test kits recalled. In fact, this recall is an extension of a voluntary recall issued by Ellume in October. At the time, almost 430,000 kits were recalled, but the FDA bumped that up to the current numbers and reclassified it as the highest possible Class 1.

If you have test kits at home, you can check here to see if yours are impacted by the recall. The company is offering a replacement after completing the form. You can also call Ellume at 1-888-807-1501 if you have any questions.

Keep reading

Use this calculator to determine your risk of contracting COVID-19

Keep your COVID vaccine card safe with a holder – A 5-pack is $6 right now

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have regarding a medical condition, advice, or health objectives.

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