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July 26, 2021 10:31 pm

Nick Rizzo

July 26, 2021 10:26 pm

THIS IS A HUGE BREAKING STORY FOLKS! I wish I could say I was wrong about this, but sadly I guess I wasn’t. Remember last year when everyone was rushing out to get “rapid tested” for COVID-19? The mos... View MoreTHIS IS A HUGE BREAKING STORY FOLKS! I wish I could say I was wrong about this, but sadly I guess I wasn’t. Remember last year when everyone was rushing out to get “rapid tested” for COVID-19? The most popular rapid test was the nasal swab, where they basically swabbed the underside of your brain via your nasal cavity and then did it a second time in the other nostril? Nothing about it ever sat right with me, and whenever I see them pushing something like this on the mass population, my red flags go off. Turns out, I was right…..those swabs weren’t safe at all or accurate because they have just been recalled by the FDA in a Class I recall. From FDA.gov itself, take a look: Yeah, a little late for a recall there FDA, don’t you think? No one is using them anymore, but good on you for “recalling” them. Are you also going to recall all the fake data they produced? All the millions of false positives? We all knew these things were funky from the beginning! Remember when Elon Musk did 4 tests at one time and got 2 positive and two negative? His exact quote: “Something extremely bogus is going on here.” Follow on Telegram @WeLoveTrumpNoah Turns on the eccentric billionaire genius rocket scientist was right again, image that. Here’s more on the story: “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.” https://t.co/Bapfo7sKfR — Katie Pavlich (@KatiePavlich) July 25, 2021 The FDA announced today that the CDC PCR test for COVID-19 has failed its full review. Its Emergency Use Authorization has been REVOKED. It is a Class I recall. The most serious type of recall. Too many false POSITIVES!https://t.co/NXo4fOSVdg — 404_Not_Found (@4_04_Not_Found) July 25, 2021 PCR test to be withdrawn – not fit for purpose! The FDA announced today that the CDC PCR test for COVID-19 has failed its full review. Its Emergency Use Authorization has been REVOKED. It is a Class I recall. The most serious type of recall. Too many false POSITIVES! pic.twitter.com/XN1JTWJpEd — Fran (@Fran73113786) July 22, 2021 Served its purpose? Inflated the false positives? Could it be once again that false positive tests are being used to help the numbers surge? Innova Medical Group Recalls Unauthorized SARS-CoV-2 Antigen Rapid Qualitative Test with Risk of False Test Results | FDA https://t.co/gyZPCsjLrU — Fat Dragon Productions (@fatdragonpro) July 17, 2021 Basically what we are all thinking right now: Are you freaking kidding me? https://t.co/exEqkFxl4w — Steve Deace (@SteveDeaceShow) July 25, 2021 Here is the FULL info direct from the FDA.gov website, read it for yourself folks: 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: FDA-Authorized Molecular Diagnostic Tests for SARS-CoV-2 FDA-Authorized Antigen Diagnostic Tests for SARS-CoV-2 Report any problems you experience with the Innova SARS-CoV-2 Antigen Rapid Test to the FDA, including suspected false results.

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https://www.fda.gov/medical-devices/medical-devi ce-recalls/innova-medical-group-recalls-unauthorized-sars-cov-2-antigen-rapid-qualitative-test-risk-false-test

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