End the Lockdown

Danbones

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Sep 23, 2015
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CDC Capitulates - Declares PCR Tests as UNFIT to Diagnose Covid.​

Audience: Individuals Performing COVID-19 Testing

Level: Laboratory Alert

After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only. CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives.

Visit the FDA website for a list of authorized COVID-19 diagnostic methods. For a summary of the performance of FDA-authorized molecular methods with an FDA reference panel, visit this page.

In preparation for this change, CDC recommends clinical laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay select and begin their transition to another FDA-authorized COVID-19 test. CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses. Such assays can facilitate continued testing for both influenza and SARS-CoV-2 and can save both time and resources as we head into influenza season. Laboratories and testing sites should validate and verify their selected assay within their facility before beginning clinical testing.


THERE: the PCR TESTS ARE "UNFIT FOR PURPOSE " The whole thing has been total BS from day one. The CDC is NOW directing Labs to use tests that distinguish between COVID and the FLU.
:)
Where the hell is this in the sleepy approved media eh?...
;)
and all those people's whose lives have been totally fked by the BRAINDED STOOOPID "BELIEVERS".

Have a nice day all you lab mice... HaHa...got your covid assports yet?
 

Danbones

Hall of Fame Member
Sep 23, 2015
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Geeez....the actual counts in the US VOTE audits....the news the FBI false flagged the capitol on Jan 6...this news.....^ from the CDC...
;)
"conspiracy theorists", eh?


I feel good today. Schadenfreude is well worth the crap it takes to enjoy when it is at the expense of the self inflicted.
:)
 

Danbones

Hall of Fame Member
Sep 23, 2015
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Well well well stoopid, howya doin?​


Innova Medical Group Recalls Unauthorized SARS-CoV-2 Antigen Rapid Qualitative Test with Risk of False Test Results​

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product​

  • Innova SARS-CoV-2 Antigen Rapid Qualitative Test (also distributed under the names Innova COVID-19 Self-Test Kit (3T Configuration), Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration), and Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration))
  • Lot codes:
    • 25T (25 tests per box) - U2101750, U2101751, X2006004, X2008001, X2008010, X2009002, X2009004, X2009013, X2009016, X2010004, X2010010, X2011005, X2011006, X2011007, X2011008, X2011009, X2011012, X2011013, X2011015, X2011016, X2011017, X2011025, X2011051, X2011052, X2012001, X2012002, X2012004, X2012005, X2012008, X2101002, X2101004, X2101014, X2101031, X2101038
    • 3T (3 tests per box) - U2102003, X2012310
    • 7T (7 tests per box) - U2101748, U2102001, U2102002, X2012711, X2103792
  • Manufacturing Dates: September 1, 2020 to March 3, 2021
  • Distribution Dates: November 2, 2020 to March 22, 2021
  • Devices Recalled in the U.S.: At least 77,339
  • Date Initiated by Firm: March 24, 2021

Device Description​

The Innova SARS-CoV-2 Antigen Rapid Qualitative Test claimed to determine if a person has an active COVID-19 infection. The test used a nasal swab sample and test strip to detect specific proteins, called antigens, from the SARS-CoV-2 virus. If the nasal sample had SARS-CoV-2 antigens, a colored test line should have appeared on the test strip, indicating that the person may have COVID-19. If the nasal sample did not have SARS-CoV-2 antigens, a colored line should not have appeared on the test strip. The test has not been authorized, cleared, or approved by FDA for commercial distribution in the United States.

Reason for Recall​

Innova Medical Group is recalling its SARS-CoV-2 Antigen Rapid Qualitative Test. Labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests. The performance characteristics of the test have not been adequately established, presenting a risk of false results.

  • False-negative results may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause patient harm including serious illness and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when presumed negative patients are grouped into cohorts in health care, long-term care, and other facilities based on false test results.
  • False-positive results could lead to a delay in the correct diagnosis and the initiation of an appropriate treatment for the actual cause of patient illness, which could be another life-threatening disease that is not SARS-CoV-2. False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive patients are grouped into cohorts based on false test results.

Who May Be Affected​

  • People who were tested using these devices
  • Health care providers who may have access to and use these tests or whose patients have used these tests
  • Organizers of large testing programs, such as on college campuses, who may be using and distributing these tests for diagnostic use

What to Do​

On April 23, 2021, Innova Medical Group sent all affected device users an Urgent Medical Device Recall letter. The letter provided the following information:

  • Do not use these tests to screen for or diagnose COVID-19.
  • Identify and remove all affected tests from inventory.
  • Either destroy the tests by placing them in the trash or return the tests using the FedEx return label that was included with the letter Innova sent to its customers.
  • Complete and return the form Innova sent to its customers, indicating the number of destroyed or returned tests.
The FDA also recommends:

  • Test users and caregivers: Talk to your health care provider if you think you were tested with the Innova SARS-CoV-2 Antigen Rapid Qualitative Test and you have concerns about your test results.
  • Health care providers: If the test was given less than two weeks ago, consider retesting your patients using a different SARS-CoV-2 diagnostic test if you suspect an inaccurate result. If testing was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.
  • Testing program organizers:Notify participants in your testing program to discontinue diagnostic use of these tests and to use an FDA-authorized test to continue testing. For listings of FDA-authorized tests, see:
  • Report any problems you experience with the Innova SARS-CoV-2 Antigen Rapid Test to the FDA, including suspected false results.
For more information, please see the FDA's June 2021 safety communication, Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test.

 
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Twin_Moose

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Apr 17, 2017
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Like a few of us were saying since last fall the PCR tests were throwing false positives and there was no Flu because they were counted as COVID

07/21/2021: Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing


Audience: Individuals Performing COVID-19 Testing

Level: Laboratory Alert

After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only. CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives.

Visit the FDA website for a list of authorized COVID-19 diagnostic methods. For a summary of the performance of FDA-authorized molecular methods with an FDA reference panel, visit this page.

In preparation for this change, CDC recommends clinical laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay select and begin their transition to another FDA-authorized COVID-19 test. CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses. Such assays can facilitate continued testing for both influenza and SARS-CoV-2 and can save both time and resources as we head into influenza season. Laboratories and testing sites should validate and verify their selected assay within their facility before beginning clinical testing.

Does the Biden administration want COVID to go away? Is that why they are after more accurate testing now?
 
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Twin_Moose

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Twin_Moose

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Apr 17, 2017
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That's not new....
I said back in June that getting the vaccine is for YOUR protection only. you still have to wear a mask when going into a store!
The mask was suppose to be for others protection from you, if you're vaccinated what are you protecting me from? And what am I protecting you from? Catching a cold or the flu?
 

Twin_Moose

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Apr 17, 2017
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If masks work why vaccinate? if vaccinations work why mask?

Or maybe the vaccinations are not so goodInventor of mRNA Vaccine: Some Covid Vaccines Make the Virus More Dangerous
By Larry Johnson
Published July 28, 2021 at 8:48pm
1173 Comments

In the article

Dr. Malone has warned of this risk for several months. What are we to do? Malone says that instead of relying on the flawed vaccines, Doctors should use drugs for treating Covid that have proved effective, such as Ivermectin (more about that following the video), is neutralizing Covid:

What should scare the hell out of you is the extraordinary efforts being taken to silence and discredit Dr. Malone. I encourage you to read Michael Haynes piece from July 5, which details Malone’s Kafkaesque ordeal. Here are some relevant paragraphs from his article:

Information about the inventor of the mRNA technology used in certain COVID-19 vaccines was removed from the online encyclopedia site Wikipedia after he publicly warned against giving the experimental gene therapy vaccines to young people and that there was insufficient information about the injections to give informed consent. . . .
On June 10, 2021, Dr. Malone joined biologist Bret Weinstein, Ph.D, on the Dark Horse Podcast, where Malone raised numerous safety concerns about the Pfizer-BioNTech and Moderna COVID-19 vaccines, both of which use mRNA technology. He warned about future autoimmune issues caused by the spike proteins within the mRNA injections.
Malone also stated that the Food and Drug Administration (FDA) was aware that the spike proteins were “biologically active and could travel from the injection site and cause adverse events, and that the spike protein, if biologically active, is very dangerous.”



The same effort to discredit Dr. Malone also has been unleashed against non-vaccine treatment methods. Remember what happened to anyone who dared suggest using Hydroxychloroquine or Ivermectin?

And do you remember the news stories in May about how Covid was devastating India? I bet you have heard little about the efficacy of Ivermectin in stopping Covid in Dehli.

Dr. Pierre Kory told the world on December 8, 2020, that Ivermectin “obliterates” this virus. Obliterate means to decimate, demolish, or annihilate. It means to eliminate or destroy all trace, indication, or significance.

This graph shows that Ivermectin, used in Delhi beginning April 20, obliterated their COVID crisis. No one should be able to talk you out of this – not a salesman, a drug company, a television celebrity doc, and certainly not the top doctor for the WHO or the NIH who is paid to do that.
 
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DaSleeper

Trolling Hypocrites
May 27, 2007
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Northern Ontario,
The mask was suppose to be for others protection from you, if you're vaccinated what are you protecting me from? And what am I protecting you from? Catching a cold or the flu?
If i'm vaccinated I can still be a carrier....I just don't get sick from it!
Why is that so hard to understand?