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Ellume has recalled over two million of its at-home coronavirus tests because of a “higher-than-acceptable” number of false positives.

The recall has been classified by the Food and Drug Administration as a Class I recall, considered to be “the most serious type of recall” as use of the tests may cause serious adverse health consequences or death, the agency said, CNN reported.

Included in the recall are tests produced from Feb. 24 to Aug. 11 and distributed from April 13 to Aug. 26.

The FDA said there have been 35 reports of false positives but no deaths. The accuracy of any negative test results is not in question.

The agency said false positives could lead to a delayed diagnosis or treatment of the actual cause of a person’s illness, unnecessary COVID-19 treatment which may have side effects, and disregard for precautions against the disease, including vaccination, CNN reported.

CNN reported the FDA is working with Ellume to monitor the company’s corrective actions to ensure that the issues are resolved.

Additionally, Ellume has requested the affected products be removed from shelves and that those who have tested positive get a follow-up test to confirm the diagnosis.

WI Guest Author

This correspondent is a guest contributor to The Washington Informer.

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