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11/12/21 - COVID-19 Home Test Kit Recalled

Friday, November 12, 2021 at 7:59 AM

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Certain lots of the Ellume COVID-19 Home Test are being recalled due to multiple reports of false positive results.

The FDA  announced a recall of some 2.2 million at-home  Ellume COVID-19 tests.

The Class I recall impacts  certain lots of the Ellume COVID-19 Home Test “because they have higher-than-acceptable false positive test results” for SARS-CoV-2 (COVID-19). The reliability of a negative test result is not in question as part of the issues with the test.

The tests were manufactured from February 24, 2021 to August 11, 2021 and were distributed between April 13, 2021 and August 26, 2021.

Ellume tests are available to anyone without a prescription and also uses an analyzer that connects to a smartphone app which helps users understand how to perform the test and interpret the results, according to the FDA.

To determine if your Ellume test is one of the recalled lots, first find the lot numbers on the sticker on the side of the package. Then visit the FDA website to find the catalogue and master lot numbers.

You can also visit the Ellume website to determine if your test is affected by the recall and to request a new one.

 

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