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PROVIDENCE, R.I. (WPRI) — A manufacturing issue has prompted Ellume to recall certain lots of its COVID-19 Home Tests, the U.S. Food and Drug Administration (FDA) reports.

The issue may cause the tests to give “false positive” results, indicating the user is infected with the coronavirus when they are actually not, according to the FDA.



Consumers who bought a test kit from Ellume are advised to check to see if it’s included in the recall by comparing the lot number on the side of the carton to the affected lot numbers on the company’s website.

The FDA said anyone who has an unused test from the affected lots should request a replacement on Ellume’s website.

Anyone who received a positive result using one of the affected test kits in the past two weeks is urged to confirm it by getting a COVID-19 molecular diagnostic test from their health care provider, an urgent care center or other test site.

The FDA said it’s working closely with Ellume to make sure the issue is resolved.

Visit the FDA’s website to learn more.



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