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At-home COVID-19 tests recalled kits amid false-positive results – Portland, Oregon

Portland, Oregon 2021-10-04 18:38:22 –

Portland, Oregon (KOIN) — The Ellume brand home COVID-19 test recalls many kits after an increase in false-positive test results.

The company said it worked with the U.S. Food and Drug Administration to remove affected tests from the market, identify the cause, and confirm that the incidence of this false positive was limited to a specific lot number. rice field. Click here for specific lot numbers..

When asked why the problem was causing the recall, an Ellume spokeswoman said: “The increase in false positives was the result of a supply chain problem with one of the test components. We cannot provide any further details due to proprietary information related to the manufacturing process.”

If you want to take the Ellume at-home COVID-19 test and see if the test is part of a recall, click here Enter the analyzer ID number and zip code.

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

According to the website, “We apologize for the complexity of the form, but we need to track false positive results and report them to the FDA.”

The company said it would issue exchange tests to affected people.

At-home COVID-19 tests recalled kits amid false-positive results Source link At-home COVID-19 tests recalled kits amid false-positive results

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