FDA Recalling 2 Million Ellume At-Home COVID-19 Test Kits for False Positives

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The U.S. Food and Drug Administration (FDA) has announced a recall of about 2 million at-home COVID-19 test kits manufactured by Australian-based biotech company Ellume.

According to an NPR news report, the federal regulatory agency says these test kits may produce false positives because of a manufacturing defect. The company initially informed the FDA about the defect in some lots in October.

Manufacturing Defect

This week, the FDA said it has identified additional lots that have been impacted by the manufacturing defect. The defective tests were manufactured by Ellume between Feb. 24 and Aug. 11. So far, 35 false positives from these tests have been reported to the FDA. The FDA labeled this as a Class I recall, which is the most serious category of recalls. Earlier this year, the Biden administration made a $231.8 million deal with Ellume to boost the availability of COVID-19 tests in the U.S. Ellume’s contract with the U.S. government helped fund the company’s first plant in the country, which is located in Maryland.

The test kits consist of an over-the-counter nasal swab that can be purchased at a pharmacy or grocery store. The convenience of the tests is that they can be taken at home. These at-home kits detect small parts of the virus that causes COVID-19 and have a record of providing fairly reliable results in just 15 minutes, particularly in people who are experiencing symptoms.

The FDA and Ellume say that the reliability of the negative tests has not been affected by the problem that they found in the defective test kits. Ellume has said it has corrected the manufacturing issue and federal regulators have said they are monitoring the company’s efforts moving forward. That means FDA officials are working with Ellume to evaluate the company’s corrective actions such as additional checks during manufacturing so this problem will not recur. Over-the-counter at-home test kits have increased in popularity as the pandemic has continued on.

What Steps Can You Take?

If you have one of these test kits at home, check if it’s part of the recall by comparing the lot number on the test carton to the lot numbers on Ellume’s website. If you tested positive for COVID-19 using one of the affected test kits, contact your healthcare provider, an urgent care facility, or another COVID-19 testing site to request a COVID-19 molecular diagnostic test. If you have an unused recalled test kit at home, use the Ellume Home Test App or follow the directions on the company’s website to request a product replacement.

If you or a loved one has been affected by these or other defective products, you may be able to seek compensation for your injuries and losses by filing a product liability lawsuit against the manufacturer. An experienced product defect lawyer can help you better understand your legal rights and options.

 

Source: https://www.npr.org/2021/11/11/1054606822/fda-recalling-2-million-ellume-at-home-covid-19-test-kits-because-of-false-posit

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