Second recall and warning by FDA indicate a strong crackdown on unauthorized COVID-19 tests
The US Food and Drug Administration (FDA) issued its second Class 1 recall (the most serious recall the FDA uses) of a COVID-19 test. This one comes less than two weeks after the FDA recalled another COVID-19 test for similar issues.
The first recall occurred May 28, 2021, and it applied to COVID-19 tests sold by Lepu Technology without authorization (See FDA Issues Public Safety Communication Warning Public and Healthcare Providers About COVID-19 Tests Sold By Lepu Technology).
On June 10, 2021, the FDA issued the second and most recent Class 1 recall for COVID-19 testing. Simultaneously, the FDA provided a letter to the public and to healthcare providers, warning them to immediately stop using the affected tests. The test affected by the second recall is the Innova SARS-CoV-2 Antigen Rapid Qualitative Test.
The FDA cited multiple reasons for issuing the warning and recall, including the fact that the test’s performance was not adequately established; the fact that the test had not yet received authorization; and concerns that the data provided by the Innova Medical Group with their emergency use authorization (EUA) application appeared to be copied from data provided by other test manufacturers.
The FDA warns that the Innova SARS-CoV-2 Antigen Rapid Qualitative Test is sold under many names, including:
- Innova COVID-19 Self-Test Kit (3T Configuration)
- Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration)
- Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration)
The FDA recommends that healthcare providers who have used the Innova SARS-CoV-2 Antigen Rapid Qualitative Test retest any patients who may have experienced an inaccurate result.
Related Resources:
FDA: Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety Communication
STAT: FDA accuses company of distributing unapproved Covid test and using falsified data
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Comments (7)
Herb Rose
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They issued an immediate recall because the test had not been established to give the 99% wrong answers like the authorized tests? This is their idea of danger while the thousands being sickened and killed by the toxic vaccines are deemed acceptable, requiring no stop and desist action? They will approve a drug for Alzheimer that has no evidence of being effective, on the chance it might be of some benefit without any idea of what adverse effects it might have. This is beyond ignorance, stupidity, and incompetence and their retirement plans should be free room and board for life, in a federal prison.
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Barry
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Totally agree Herb. This is beyond incompetence and is bordering on at least manslaughter if not out right murder. Nuremberg code makes no excuses for following orders.
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Jackie
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What he is referring to is ‘sterilising immunity’, like you are vaccinated once and are immune to the disease for life. These jabs do not appear to do this as you can still become infected and infectious.
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very old white guy
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the jabs do not present anything that can cause immunity to anything. The spike protein is the be all end all in this latest round of insanity.
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SteveT
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This is referring to LFT tests, which have a 20 minute test result, not PCR tests which are sent to a lab, and the result is back within 24 hours. The article is not quite correct.
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Andrew Pilkington
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But NOTHING at all about the PCR “and” the LFT Nasopharyngeal ( “Nasal”) Swabs being “Sterilized by Ethylene-Oxide Gas”, (” EO”)? NOTHING and no one gives a damn, that this Deadly Carcinogen is being rammed up their Nose, virtually to the Brain, an depositing it’s Contaminated fibres there, when it is pulled out?
It is Mass Murder and no one wants to know? WTF (Yes! I honestly thing we should be Swearing, at least on this Subject because it could be the Biggest Killer? Affecting far more than their “Death Jabs”?
PLEASE, just read the packaging and look it up.
These “may” help you see the danger here and it’s with thanks to Retired Police Constable “Mark Sexton”, via his Facebook page (at least?), over here in England. And, former Nurse and Medical Innvestigator “Cassandra S. Dunn”, over in the USA, for exposing this threat.
See what you think, please:
https://brandnewtube.com/v/PQH3IS
and
https://brandnewtube.com/v/4OwTtO
This is Very Real and it’s being ignored.
Thank you.
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Syrius33
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He aquí la prueba irrefutable de la doble moral y la peligrosidad que conlleva para la humanidad ese papel hegemónico que asume y se le ha concedido tácitamente a una FDA corrupta, permeada al igual que la OPS/OMS hace tiempo por intereses económicos y políticos de oscuro fondo. ¿Con qué derecho suprime esta PCR, “porque no está autorizada” y porque es “peligrosa”?????
Y los productos que ellos mismos han “autorizado para uso de emergencia”, ¿ qué patente tienen??, ¿ qué seguridad tienen???, ¿ qué estudios y pruebas científicas tienen??? ¿si son unos productos ilegales, homicidas, inoculados por autorización de ellos mismos con publicidad y argumentos falsos y engañosos, con qué autoridad censuran???? Ya la FDA no tiene derecho ni autoridad legal ni moral para censurar nada, porque ella misma, como entidad, es censurable en su proceder, en su conducta.
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