Date Issued: June 10, 2021
"The U.S. Food and Drug Administration (FDA) is warning the public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health. In addition, 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. Finally, the test has not been authorized, cleared, or approved by the FDA for commercial distribution or use in the United States, as required by law."
The Innova SARS-CoV-2 Antigen Rapid Qualitative Test is 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).
On April 23, 2021, Innova Medical Group recalled their Innova SARS-CoV-2 Antigen Rapid Qualitative Test. The FDA has identified this recall as a Class I recall, the most serious type of recall."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."
Stop Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody Tests: FDA Safety Communication
Date Issued: May 28, 2021I wonder why the fake news media in the U.S. apparently never mentioned these FDA warnings.
The U.S. Food and Drug Administration (FDA) is warning the public to stop using the Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography). The FDA has serious concerns about the performance of the SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) and believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared or approved by FDA for distribution and use in the United States.
Lepu Medical Technology is recalling their SARS-CoV-2 Antigen Rapid Test Kit and their Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography). The FDA is aware that these unauthorized tests were distributed to pharmacies to be sold for at-home testing by consumers as well as offered for sale directly to consumers.
The only media I could find the article on was in the Daily Mail, a British publication...Americans are told to STOP using controversial rapid Covid test that Britain has spent £2.8BILLION on because it doesn't work as well as manufacturer claims!
To be honest, the only reason I knew about it was because an ANON, who happens to be a nurse, sent a video to the Patriots warning them about the email she just received from the FDA regarding the June 10, 2021 warning. I found the May 28, 2021 warning after doing a search on the FDA website:
She must be one of those conspiracy theorists the cabal keeps mentioning; you know the ones who just happen to have the facts in hand before they speak.
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