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Home COVID tests recalled over false positive results

According to the FDA, certain lots of the test indicate that a person has the virus when they...
According to the FDA, certain lots of the test indicate that a person has the virus when they do not actually have it. Negative results do not appear to be affected by the manufacturing issue.(Source: Ellume, Food and Drug Administration)
Published: Oct. 6, 2021 at 9:13 AM MST
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(Gray News) – The Food and Drug Administration is recalling the Ellume COVID-19 Home Test over false positive results.

According to the FDA, certain lots of the test indicate that a person has the virus when they do not have it. Negative results do not appear to be affected by a manufacturing issue.

“The FDA is working closely with Ellume to assess the company’s additional manufacturing checks and other corrective steps to help ensure that the issue is resolved,” a safety communication from the agency said.

A complete list of recalled Ellume COVID-19 Home Tests can be found on the company’s website.

If you purchased one of the recalled test kits, you can request a replacement by completing an online form.

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