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At-Home COVID Tests Being Recalled Due to False-Positive Results

Several at-home COVID-19 tests are being recalled after it was discovered that they were incorrectly providing false-positive results.

In a statement, Ellume, the manufacturer of the tests, said, “In recent weeks, we noted an increased chance that Ellume COVID-19 Home Tests from specific lots may provide an incorrect positive result. Following a thorough investigation, we isolated the cause and confirmed that this incidence of false positives is limited to specific lots.”

According to Ellume, the company has worked with the U.S. Food and Drug Administration (FDA) to issue the voluntary recall and remove the affected at-home test kits from the market. The statement said that the tests included in the recall were distributed from April 2021 to August 2021.

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