200K COVID Testing Kits Recalled After Giving False Positive Results Due To Unknown Manufacturing Issue

More than 200,000 COVID testing kits have been recalled after they gave false positive results due to an unknown manufacturing issue.

Ellume, an Australian company that supplied over 3.5 million FDA-approved Covid-19 testing kits to the US, has now recalled nearly 200,000 of them due to an unspecified manufacturing issue that resulted in false positives.

The Food and Drug Administration issued a notice on Tuesday alerting the public of “the potential for false positive results” with certain lots of Ellume’s Covid-19 Home Test, a rapid antigen kit used to detect the coronavirus using nasal swabs and a smartphone app.

Today, the @US_FDA issued a safety communication to alert test users, caregivers, health care personnel, and the public of the potential for false positive results with certain lots of the Ellume #COVID19 Home Test due to a recently identified manufacturing issue. pic.twitter.com/uYSJ9U4DBu

— FDA Medical Devices (@FDADeviceInfo) October 5, 2021

“Negative results do not appear to be affected by the manufacturing issue,” the FDA said, adding it is “working closely” with Ellume to assess “corrective steps” going forward.

People who used an Elume kit and received a positive result were instructed to contact their healthcare provider for a follow-up.

Everyone who owns a kit is urged to check the Ellume-provided list of problematic lots, sent out between April and August this year, and request a replacement after submitting receipts.

Ellume CEO Dr. Sean Parsons said the company noticed the false positive result from specific product lots “in recent weeks” and isolated the cause.

However, the company declined to elaborate what was causing the problem, citing trade secrets.

“The increase in false positives was the result of a supply chain issue with one of the test components. Because of the proprietary information involved in the manufacturing process, we cannot offer more specifics,” an Ellume spokesperson said in a statement.

While neither the FDA nor Ellume gave the exact amount of kits that are being recalled, the New York Times said the number was “nearly 200,000.”

A total of 427,000 kits sent to the US have been affected by the unspecified issue, and half have already been used, resulting in about 42,000 positive results, the paper said.

It was unclear how many of those positives may have been false.

Ellume has shipped approximately 3.5 million test kits to the US after receiving FDA emergency use authorization in December as the first over-the-counter completely at-home Covid-19 test. 

At least four of the lots listed on Ellume’s recall page were sent to the US Department of Defense.

The Pentagon awarded Ellume a $238 million contract in February, to increase the production of its tests in the US.

The mainstream media is obsessed with reporting new coronavirus cases daily. But how many of them are really genuine cases and how many are false positive COVID-19 cases?

The WHO’s testing protocol was even questioned by Finland’s national health authority. WHO had called on countries to test as many patients as possible for coronavirus.

Finland ran out of testing capacity and began limiting coronavirus tests to the most vulnerable groups and healthcare personnel only. Finland’s national health authority said that testing people with mild symptoms would be a waste of healthcare resources.

In a startling disclosure, Finland’s head of health security, Mika Salminen dismissed WHO advisory saying the WHO doesn’t understand pandemics and that their Coronavirus testing protocol is illogical and doesn’t work.

In the past in 2010, the WHO was caught faking a pandemic and was forced to admit that its methodology of measuring the virality or the spread of the disease, instead of its severity was incorrect.

Even now, you aren’t legally allowed to know which variant gave you COVID-19, even if it’s Delta. No test exists for any variant of Covid, and no laboratory anywhere is planning to make one.

Its an open COVID-19 variant fraud and why they won’t tell you which variant you are infected with.

Also, the CDC has revoked the emergency use authorization given to RT-PCR for COVID-19 testing.

Numerous courts around the world have determined the use of RT-PCR for detection of SARS-COV-2 as unreliable and downright fraudulent.

A Portuguese appeals court has ruled that PCR tests are unreliable and that it is unlawful to quarantine people based solely on a PCR test.

Similarly, the Austrian court has ruled that PCR tests are not suitable for COVID-19 diagnosis and that lockdowns has no legal or scientific basis.

Then an Austrian parliamentary member exposed the defectiveness of the government’s COVID-19 tests by demonstrating in the parliament how a glass of Coca Cola tested positive for COVID-19.

Even the World Health Organization (WHO) itself took a u-turn and changed its PCR test ctiteria cautioning experts not to rely solely on the results of a PCR test to detect the coronavirus.

Meanwhile, according to numerous shocking reports, COVID vaccines found to be contaminated with stainless steel and rubber fragments are killing people in Japan. Pink, white and black substances were also found floating in the vials.

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