Millions of Ellume COVID-19 home tests recalled over manufacturing defect

More than 2 million over-the-counter COVID-19 home tests are being recalled, according to the U.S. Food and Drug Administration who classified the recall as a Class 1, the most serious type of recall.

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The biotech company Ellume is recalling the at-home tests because the company said it is seeing higher-than-acceptable numbers of false positive test results for SARS-CoV-2, or COVID-19.

A false positive test result means that the test shows a person has the COVID-19 virus when they do not.

The home test, which tests for antigens, does not require a prescription. The sample tested is taken by using a nasal swab inserted into the person’s nose.

The FDA says the test kits may produce “false positives” due to a manufacturing defect.

The defective tests were manufactured by Ellume between Feb. 24, 2021 and Aug. 11, 2021. So far, 35 false positives from these tests have been reported to the FDA, according to the agency.

Earlier this year, the Biden administration made a deal to buy $231.8 million worth of Ellume tests to boost the availability of home tests in the U.S.