Wichita, Kansas 2021-10-05 09:35:12 –
A replacement test will be issued to those affected
After increasing false positive test results, the number of Ellume brand home COVID-19 test kits has been recalled.
The company said it worked with the US Food and Drug Administration to remove affected tests from the market. Ellume also states that it has identified the cause and confirmed that the incidence of this false positive is limited to a particular lot number. Click here for specific lot numbers..
When asked about the cause of 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.
“We apologize for the complexity of the form, but we need to track false positive results and report them to the FDA,” the website said.
The company said it would issue exchange tests to affected people.
At-home COVID-19 tests recalled amid false-positive results Source link At-home COVID-19 tests recalled amid false-positive results