There is no question that these COVID-19 test kits are going to make you see red and here is the reason why…
Last October, there was a problem with the home COVID-19 test kits that had been produced by an Australian company named Ellume. It prompted a recall of 200,000 kits. This in-home COVID-19 test kit had been given emergency authorization by the FDA so that it could be used by individuals as young as two years old to detect this Chinese virus. Once the recall occurred, Sean Parsons, the CEO of the company, actually apologized to the New York Times:
“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 FDA is now announcing that it is going to recall over 2 million Ellume at-home COVID-19 because – surprise, surprise – there have been a plethora of “false positive” results related to the manufacturing defect in the product.
From the FDA website:
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.
Interestingly enough, both the FDA and the makers of the Ellume test took their sweet time broadcasting the fact that the product was subject to a recall. Could it have been the almighty dollar maybe? For several days after the initial announcement, these stores would either say that the product was “Sold Out” or take the user to a broken page. Apparently, they have finally caught up now, because most of these websites now say that this product is subject to a “voluntary recall.” No, their heart isn’t in it, but at least they are making a halfhearted attempt to do the right thing. Oh brother.
The description for the in-home test on the Ellume website read the following:
“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.”
Even with all of this recent controversy, the Ellume website is still fond of boasting that their home COVID-19 test is 96% accurate.
The Epoch Times is now reporting that the firm had first informed the federal regulatory agency about the defect in some of these lots as early as last October. On Wednesday, the FDA said it had identified some of the additional lots that had been affected by this manufacturing defect, and most of these had been produced between February 24, 2021, and August 11, 2021.
At the date of this writing, there have been at least 35 false positives from these COVID-19 tests that have been reported to the FDA. Fortunately, there have been no deaths reported from the defect in this test, according to the agency.
If there is a “false positive” it would indicate that an individual has contracted the CCP (Chinese Communist Party) virus even if they do not actually have COVID in reality.
The FDA also noted that these false positives could lead to a “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.”
Yet another problem according to the FDA would be that there would be “isolation, including monitoring household or close contacts for symptoms, limiting contact with family or friends, and missing school or work.”
The Biden Administration had originally signed a $231 million deal with Ellume, who had initially received approval to produce these tests under the Trump Administration last year.