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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's 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 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.
"Ellume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S.," a company representative said, The New York Times reported. "Importantly, not all of the positive results of the affected tests were false positives, and negative results were not affected by this issue."
A false positive test result shows that a person has the virus when they do not have it, which could pose a number of risks, including:
- Delayed diagnosis or treatment for the actual cause of the person's illness, which could be another life-threatening disease that is not COVID-19.
- Further spread of the coronavirus when people who are believed to be positive are housed together based on false test results.
- Unnecessary COVID-19 treatment — such as antiviral treatment, convalescent plasma, or monoclonal antibody treatment — which can cause side effects.
- Ignoring recommended precautions against COVID-19, including vaccination.
- Isolation, including monitoring household or close contacts for symptoms, limiting contact with family or friends, and missing school or work.
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 with the recalled lot numbers. Ellume will inform customers who used an affected test and received a positive result.
The FDA said you should contact your health care provider, urgent care facility or other COVID-19 testing site if you 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 you did not receive a positive result from a different COVID-19 test at the time of the original Ellume positive test result.
A health care provider can help you decide what next steps you should take, the FDA advised.
The agency also said that if you used a test kit from the recalled lots you should not assume that you had COVID-19 or have immunity to COVID-19, and should continue to take recommended precautions, including vaccination.
Here's where to find Ellume's recall notice.
SOURCES: U.S. Food and Drug Administration, news release, Nov. 9, 2021; The New York Times
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