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The Food and Drug Administration issued an alert on Tuesday about the potential for false positive results with certain home COVID-19 tests produced by Ellume.
The tests were sold at various retailers nationwide.
“In recent weeks, we have noted an increased likelihood that Ellume’s COVID-19 home testing of specific batches may provide an incorrect positive result,” the company wrote in a statement.
The company also said that “the reliability of the negative results is not affected by this issue and is not included in this recall.”
A manufacturing problem would be at the origin of the problem. Affected test kits are removed from store shelves.
The FDA recommends verifying whether your Ellume COVID-19 home test is included in the Ellume product recall by comparing the lot number on the test carton to the lot numbers on the Ellume website.
The FDA recommends contacting your health care provider, emergency care facility, or other COVID-19 testing site and requesting a COVID-19 molecular diagnostic test if you have received a positive test result with the one of the affected lots of the Ellume COVID-19 home test. within the past two weeks and have not already had a follow-up molecular diagnostic test to confirm the positive test result.
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