More Than 2 Million COVID-19 Home Test Kits Recalled Due to False-Positive Results

A recall of Ellume at-home COVID-19 test kits has been expanded to include roughly 2 million of the 3.5 million tests that had been shipped to the United States by last month, the U.S. Food and Drug Administration said Tuesday.

The original recall, involving 427,000 kits, was first announced in early October due to a “higher than acceptable” rate of false positives. It is a Class I recall — the most serious type — because use of these tests may cause serious adverse health consequences or death, according to the FDA.

The recalled kits were made by the Australian company between Feb. 24 and Aug. 11, 2021, and were distributed in the United States between April 13 and Aug. 26. The FDA first approved emergency use of the test in December 2020 and revised its emergency use last February. The Ellume test is available without a prescription to people with or without symptoms.

There have been 35 reports of false-positive results sent to the FDA, but no deaths have been reported, according to the agency. There is no problem with the reliability of the kits’ negative test results, the FDA noted.

Customers with Ellume COVID-19 home test kits should compare the product lot number on the sticker on the side of the carton to the recalled lot numbers. Ellume will inform customers who used an affected test and received a positive result.

The FDA said patients should contact their health care provider, urgent care facility, or other COVID-19 testing site if they received a positive test result using one of the recalled lots of the Ellume COVID-19 Home Test more than two weeks ago and if they did not receive a positive result from a different COVID-19 test at the time of the original Ellume positive test result.

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