BREAKING: False Positive Results Leads To FDA Recall of Over 2 Million COVID Home Test Kits: “Use of these tests may cause serious adverse health consequences or death”
In October, a problem with home COVID test kits produced by Australian company Ellume prompted a recall of 200,000 kits. The in-home covid-19 test was given emergency authorization by the FDA to be used at home by people as young as 2 years old to detect the CCP virus. At the time of the recall Dr. Sean Parsons, the company’s CEO apologized.
“I’m very sorry that this has happened,” he told the New York Times at the time. “We’re all about chasing accuracy, and to have these false positives is disappointing.”
Today, the U.S. Food and Drug Administration (FDA) announced that it’s recalling over 2 million Ellume at-home COVID-19 test kits due to the “false positive” results that are related to a manufacturing defect.
From the FDA website:
Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results
The recall described in this notice is for the same issue that was announced in Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue FDA Safety Communication on October 5, 2021.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these tests may cause serious adverse health consequences or death.
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Curiously, as of 4;15 PM ET today, there is no indication that the in-home test, which can be purchased from a variety of online stores like Target and Amazon on the Ellume.com website, has been recalled. The stores either say the Ellume test is “Sold out” or take the user to a broken page.
The description for the in-home test on the Ellume website reads:
“We’re proud that our test is amongst the most accurate over-the-counter (OTC) antigen home tests available. Unfortunately, no COVID test is perfect, including ours, and there is a small risk of false positives with any COVID-19 test.”
Here’s a screenshot of their response to “frequently asked questions” about “False Positives:
The Ellume website also states that their in-home COVID test is 96% accurate.
The Epoch Times reports – The firm first informed the federal regulatory agency about the defect in some lots in October. But on Wednesday, the FDA said it identified additional lots that were affected by the manufacturing defect, made between Feb. 24, 2021, and Aug. 11, 2021.
To date, about 35 false positives from the COVID-19 tests were reported to the FDA. No deaths have been reported related to the test, according to the agency.
A “false positive” indicates that an individual has contracted the CCP (Chinese Communist Party) virus, which causes COVID-19, when they actually do not.
The FDA noted that false positives could lead to “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” or receiving “unnecessary COVID-19 treatment from a health care provider,” which may “result in side effects.”
Another problem, the FDA noted, is isolation, including monitoring household or close contacts for symptoms, limiting contact with family or friends, and missing school or work.”
The Biden administration had signed a $231 million deal with Ellume, which received approval to produce its tests under the Trump administration last year.
h/t: 100 Percent Fed Up