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

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    • #436878
      PADemD
      Participant
      • Total Posts: 2,339

      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
        • 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.

          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.

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

    • #436880
      djean111
      Participant
      • Total Posts: 6,439

      This test was widely used in the UK, I think.

      I don’t think anyone really knows squat about any of the numbers.  After all, we were told that governors routinely fudged the numbers, that hospitals routinely diagnosed deaths and critical treatment as Covid because they got reimbursed more, etc.  I think everyone sees what they want to see, is all.

      America is not a country, it's just a business. (Brad Pitt, Killing Them Softly)

      Everything I post is just my opinion, and, honestly, I would love to be wrong.

    • #436906
      mrdmk
      Participant
      • Total Posts: 3,586

      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

       

      To bad, the recall does not show how many of the devices were used, which would have been useful.

      Without FDA approval, it is interesting this was distributed in the first place.

      If you cannot dazzle them with brilliance, baffle them with bullshit WC Fields

      Warning DO NOT CLICK HERE!
      • #436908
        djean111
        Participant
        • Total Posts: 6,439

        So, yeah, that seems a lot for an unapproved device.  My assumption is that all Covid percentages are wild-assed guesses.  Walmart sells around eleven different at home test kits.  Who really has a handle on knowing how many people have/had Covid?  No one at all, IMO.  Especially since I have read that a lot of folks called the doctor with Covid symptoms and told to stay home.  So the symptoms could have been for something else.

        America is not a country, it's just a business. (Brad Pitt, Killing Them Softly)

        Everything I post is just my opinion, and, honestly, I would love to be wrong.

    • #436930
      jbnw
      Participant
      • Total Posts: 5,343

      Qualitative is subjective. I would want quantitative, based on measured data.

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