Posted on 06/21/2021 8:10:08 AM PDT by bitt
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. For more information, please see the FDA's June 2021 safety communication, Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test.
Contact Information
Customers with questions about this recall should contact Linda Weinreb at Linda.Weinreb@innovamedgroup.com or call 747-494-0852.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.
p
To quote a well known corrupt career politician,
“Well Son of a Bitch”
How many false positives were generated by the test prior to recall? 10 million? 100 million? 500 million? What is the scope of damage? Shutting down planet earth?
Just wait until they find that they used this faulty Innova test to disqualify six-stroke leader Jon Rahm from the PGA tournament last week. Then we’ll have some real fireworks.
This is a rapid antigen test. They aren’t used for case diagnosis. They’re a quick and cheap (but less accurate) way for people to get themselves tested. This is not the RT-PCR test used for a case diagnosis. There is no “damage” beyond some people wasting their money on a broken test.
The PCR test was also never supposed to be used for diagnosis. The false positive for that is high and can be extremely high depending on the number of amplification cycles that run the test through.
This article isn’t about the RT-PCR test. It’s about a defective rapid antigen test. Rapid antigen tests are not used for case diagnosis. The comment I was responding to was confused about that.
Using the RT-PCR for case diagnosis is a sham. Its not meant to diagnose anything per Kerry Mullis.
The RT-PCR is typically run at 40+ cycles with a 90% false positive rate unless you are vaxxed then it is run at <= 28 cycles.
Your question is answered right in the article:
“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”
Well then its a bit more than no damage it would seem
“There is no “damage” beyond some people wasting their money on a broken test.”
I guess ALL (well this one and the PCR) testing methods are faulty/shoddy.
No telling how much wool has been pulled over our collective eyes to acheive their sick agenda/goals.
Yet, these experimental vax’s....which are causing serious adverse effects, including nearly 6,000 deaths (likely a fraction of what’s truly been reported) are still being pushed, non-stop.
🙃
A lot of wool. Enough to have millions of young healthy people gladly give up their freedoms in fear of a disease with a 99.7% survival rate. Let’s teach 7th graders about percentages instead of algebra.
The damage is the reaction to the false results on the test, or, as noted, the possible spread of the coof (lockdowns, we're ALL GONNA DIE™, etc.) based on a false negative.
Because SCIENCE!™
Liar.
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