The FDA issued an ‘safety communication’ alert, recalling hundreds of thousands of at-home coronavirus tests, after identifying the company’s testing devices were producing predominantly false positive results. These tests were authorized under emergency use authorization.
At the FDA, the only constant is change. Consistent information contradicts previous standing FDA reports and data, as new testing devices are created and immediately authorized for use under emergency use authorization (EUA). These authorizations are ultimately revised or revoked, until the devices are “fully approved” by the FDA.
Often times testing devices released under “emergency use authorization” have produced inconclusive results based upon an overwhelming amount of false positives. These misinterpreted results have corrupted the scientific medical data provided to us, tracks coronavirus outbreak across our nation.
Now, 200,000 faulty at-home COVID-19 tests in the United States have been recalled by Australian manufacturer Ellume.
These COVID-19 Home Tests are labeled for nonprescription use for ages 2-years and up. Ellume CoV-2 home test devices deliver [possibly incorrect] results in only 15 minutes.
A Timeline to Ellume’s FDA Recall
December 15th, 2020 –
Ellume was granted emergency use authorization on December 15 2020 by the U.S. Food and Drug Administration (FDA)
“Today’s authorization is a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Stephen Hahn said in a statement announcing the authorization.
“The first shipment of product to the DOD and HHS will commence in February,” Sterns said, “with 100,000 tests to be shipped to the US Government by the end of the month.”
“On Tuesday, [December 15th, 2020] the Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19 that does not require a prescription, the Ellume COVID-19 Home Test, which was developed with $30 million in support from the NIH’s RADx Tech program. HHS Secretary Alex Azar issued the following statement.”
February 1st, 2021 –
The Biden administration signed America up for a $231.8 million deal with the company. As part of the “new contract”, Ellume has committed to providing 8.5 million [questionable] tests to the U.S. federal government, said Andy Slavitt, senior adviser to the White House COVID-19 Response Team.
Suzanne Sterns, a spokesperson for Ellume, told NPR in February 2021, that the company “will be delivering 100,000 tests per month from the Australian manufacturing facility until the U.S. facility is built. At full capacity, the U.S facility will be able to produce up to 19 million tests per month. The 8.5M tests for the US government is a portion of the overall manufacturing.”
In a press release, the company said the contract made with the U.S. Defense Department, “will fund the construction of Ellume’s first manufacturing plant in the U.S. which will produce over 500,000 [potentially incorrect] tests per day,” according to the company.
May 10, 2021 –
Ellume announces its federally funded U.S. manufacturing plant. This is where the company plans to create a consistently increasing number of tests per day.
“Digital diagnostics company Ellume today announced it has established its first U.S. manufacturing facility in Frederick, Maryland to support the domestic response to COVID-19 and other infectious diseases. Once fully operational, the facility will have the capacity to produce 19 million Ellume COVID-19 Home Tests per month.”
October 5th, 2021 –
The U.S. Food and Drug Administration (FDA) alerted “test users, caregivers, health care personnel, and the public of the potential for false positive results with certain lots of the Ellume COVID-19 Home Test, due to a recently identified manufacturing issue.”
Could Ellume’s numeric priority reflect their company’s objective, producing quantity over quality?
Ellume Issues Official Recall
Ellume’s CEO issued a statement in regards to the “voluntary” recall of their faulty testing devices.
Ellume’s Statement Previous to their Recall
Previous to the recall, the Ellume website stated “the COVID-19 Home Test demonstrated 96% accuracy”. If these devices produced 96% accuracy, the FDA would not be issuing an official alert for recall.
What other testing devices and coronavirus concoctions have demonstrated “a high percentage of accuracy” from laboratory controlled “clinical testing”?
If you purchased an affected Test Kit, the company is offering a free replacement in exchange for filling out a form reporting your false positive test result to the FDA. This likely will produce further incomplete results, as it provides potential for abuse, simply to gain a free test.
Unapproved Testing Devices
“The Ellume COVID-19 Home Test has not been FDA cleared or approved; but has been authorized by the FDA under an emergency use authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Ⓒ Ellume Limited 2021”
If you think you had a problem with an Ellume COVID-19 Home Test, the FDA encourages you to report the faulty tests through the MedWatch Voluntary Reporting Form.
Faulty tests propagate faulty data providing further opportunity to operate outside the constitution, and oppress individual civil rights, at the expense of the taxpayer. Not facing any penalty, and still in full U.S. operation, should Ellume be held accountable for distributing misinformation at the expense of our tax dollars?
Could those tax resources have been used for funding something more beneficial to our American society? Should you have a say, which companies the federal government choose to invest your money? Should the American population be mandated to adhere to the fantastic restrictions for the infected, as suggested by these, and other faulty testing devices?