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FDA Issues Safety Alert For Ellume COVID-19 Tests; Warns Of False Positives

 
• By Brian Bossetta

Users of some Ellume at-home nasal swab tests might have received inaccurate results, FDA says.

POSITIVE AND NEGATIVE TEST RESULTS.
• Source: Alamy

The US Food and Drug Administration has issued a safety communication for certain lots of the Ellume COVID-19 Home Test due to a manufacturing issue. The test, according to the agency’s alert, has the potential to produce “false positive” results indicating users have the virus when they do not.

Negative results from the test, however, do not seem to be affected by the same manufacturing issue. The FDA also noted it was working with Ellume in correcting the problem....

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