2.2 Million At-Home COVID-19 Tests Just Got Recalled for a Serious Reason

2.2 Million At-Home COVID-19 Tests Just Got Recalled for a Serious Reason

by Sue Jones
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Here’s a rapid-test recall to know about: The U.S. Food and Drug Administration (FDA) is recalling more than 2 million at-home COVID-19 tests made by the Australia-based company Ellume and distributed in the U.S. The FDA is describing it as a Class I recall, “the most serious type.”

The FDA says this rapid-test recall is a result of a manufacturing defect that may lead to false positives, mistakenly telling people they are positive for the SARS-CoV-2 virus when they are not. The defect doesn’t appear to give people false negatives.

The affected Ellume tests were manufactured between February 24 and August 11, 2021. If you’ve got an Ellume test in your cabinet, use the company’s website to verify whether your batch has been affected or not. You’ll need the lot number on the side of the carton. If you’ve already used the test, they can verify whether it was affected through your app result screen or result email.

Ellume first told the FDA about the defects in October, which led the FDA to issue its first recall of more than 200,000 tests, as SELF previously reported. The FDA has since discovered more defective lots of the tests.

At press time, 35 false positives from these tests have been reported to the FDA, and businesses are being asked to remove the affected lots from their shelves.

The Ellume COVID-19 Home Test uses a nasal sample to detect proteins from the SARS-CoV-2 virus. It’s an example of a rapid antigen test, which can give people results within 15 to 30 minutes. This kind of test tends to be relatively inexpensive and, considering you can take them at home without a prescription, very convenient.

But as SELF previously reported, rapid antigen tests are not as accurate as polymerase chain reaction (PCR) tests, which are considered the gold standard. On average, rapid antigen tests only managed to accurately detect COVID-19 in 72% of people with symptoms and 58% in people without symptoms in a Cochrane review of 64 studies and more than 24,000 testing samples. PCR tests are often estimated to be around 98% accurate at detecting COVID-19 infections when used correctly.

Bottom line: Rapid antigen tests can be a useful tool against COVID-19, but they certainly aren’t the be-all, end-all of COVID-19 testing—especially when they have manufacturing defects.


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