At-home COVID-19 tests recalled amid false-positive results


Replacement tests will be issued to those affected

PORTLAND, Ore. (KOIN) – A number of Ellume brand at-home COVID-19 test kits are being recalled after an increased number of false-positive test results.

The company said it worked with the U.S. Food and Drug Administration to remove the affected tests from the market. Ellume has also said it has isolated the cause and confirmed this incidence of false positives is limited to specific lot numbers. Click here for the specific lot numbers.

When asked what caused the recall, an Ellume spokesperson said, “The increase in false positives was the result of a supply chain issue with one of the test components. Because of the proprietary information involved in the manufacturing process, we cannot offer more specifics.”

If you’ve taken an Ellume at-home COVID-19 test and want to see if your test is part of the recall, click here and enter your analyzer ID number and ZIP code.

If your test is among those impacted by the recall, you’ll be asked to upload either a proof of purchase, a screenshot of your test result or a PCR result along with your name, address and contact information.

“We apologize for the complexity of the form, but we are required to track and report false-positive results to the FDA,” the website says.

The company said it will issue replacement tests to those impacted.

Copyright 2021 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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