In an urgent field safety notice dated 2 September 2021, Abbott Diagnostics warned their customers that since July 2021 there had been a problem with their Alinity testing kits causing tests to produce false positives for Covid and that those who tested positive should be retested using another platform.
Another type of Abbott’s Covid test kits contained swabs which were not authorised for use. And a third type contains a hazardous ingredient, sodium azide.
A list of field safety notices (“FSNs”) from medical device manufacturers is maintained by the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”). In a previous article we attached a list of 24 FSNs relating to “SARS” devices between 1 January and 30 November 2021 – 15 of them relate specifically to PCR Tests and at least one relates to a lateral flow antigen test, two of these were issued by Abbott Diagnostics.
Unregistered Foam Swabs
On 27 October 2021, Abbott issued an FSN stating their ID NOW COVID-19 24 T Kit “contains foam Patient Swabs [part number 191-000] that are not registered for use in your country.”
You can read the entire FSN in the document attached below:
ID NOW was issued emergency use authorisation in the United States in March 2020. As early as May 2020 the U.S. Food and Drug Administration (“FDA”) was issuing warnings regarding ID NOW having accuracy issues.
In January 2021, the UK’s Department of Health and Social Care’s (“DHSC”) ‘Technical Validation of Abbott ID Now’ stated that positive results obtained from the ID NOW Covid test kit do not rule out bacterial infection or infection of other viruses and negative results should be treated as presumptive, “negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.”
We were unable to find proof that either Abbott’s ID NOW or Alinity Covid tests have been given approval for use in the United Kingdom although by virtue of the MHRA publishing their FSNs it would indicate the tests are available.
False Positive Results
Abbott’s Alinity Covid test kits were given emergency use authorisation in the United States in May 2020.
On 2 September 2021, Abbott issued a warning that carryover in the assay tray contributes to false positive results, two months after an increase in false positive rates was observed in July 2021.
You can read the entire FSN in the document attached below:
On 15 October – a month after Abbott issued its FSN describing a defect that could cause Covid tests to return false positive results, and three months after Abbott noticed an increase in false positive rates – the FDA upgraded the issue into a Class I recall. The Class I label indicates that the issue is a serious one. Some potential repercussions of false positives include unnecessary treatments or isolation and delayed diagnosis of the actual cause of a test-taker’s illness.
The FDA recalled all of both models of Alinity test kits due to false Covid positive results caused by the kits’ software. “For these tests, a “false positive” is a test result that indicates that a person has the virus when they do not actually have it. The false positive results may be related to the current mixing parameters for the chemicals that are combined with patient samples to detect the viruses. In some cases, the mixing parameters may cause a sample in one well of the machine’s tray to overflow into another sample well.” the FDA stated.
At the time of the Class 1 recall, these faulty software programs were responsible for analysing the results of more than 10 million already distributed tests, presumably in the United States alone.
Alinity – the same Covid test device subjected to a Class 1 recall for faulty software six weeks earlier – can detect Omicron, Sandra Ciesek tweeted. Ciesek, a German physician and virologist, was a member of a clinical advisory board for BioNTech and receives funding from Pfizer.
Less than two weeks later Ciesek tweeted that double “vaccination” does not protect from an infection with the omicron variant. Triple “vaccination” gives a 25% protection opposed to 95% for the delta variant. This tweet came a little more than a week after BioNTech’s co-founder said “Speed up the administration of a third booster shot.”
Tests Are Hazardous
“It’s critical to note that the test kits are NOT approved by the FDA. They were only given emergency use authorization (EUA) to waive manufacturer liability in case of accidents,” wrote USA Magazine Studio regarding Abbott’s BinaxNOW COVID-19 Antigen Self-Test, which, more recently, has also been brought into question for containing the “hazardous” ingredient sodium azide. “Survivors of serious sodium azide poisoning may have heart and brain damage,” according the US Centers for Disease Control and Prevention (“CDC”).
It often is cheaper for Big Pharma to break the law and pay fines than follow regulations that hinder profits. Every year at least one major drug company is fined for one or more of the following: bribery, drug safety, false claims, fraud, foreign corruption, off-label and unproven promotion, price-fixing, and violating consumer protection. Since 2000 in the US alone Abbott has been fined by federal authorities 25 times totalling $2.3bn, Before It’s News revealed.
- Under The Cover of Covid There’s a Deliberate Three-Pronged Attack on Our Health and Our Lives Using Test Swabs, Face Masks and Toxins
- Analysis of test sticks from surface testing in the Slovak Republic – confirmation of genocide, NutriTruth
- Deadly Ingredient in Abbott BinaxNOW COVID-19 Home Test Kit
- Infowars: Lethal Drug Included In Over-The-Counter Covid Test Kits (4 mins)
- Did you Know: Last Year Covid PCR Tests Were Erroneously Testing for Bacteria So Had to Be Recalled
- Following Complaints from Customers, a UK Covid Test Provider Admits Tests Cannot Be Used to Diagnose Covid
- UK’s Regulatory Agency turns a Blind Eye to Ethylene Oxide on Test Swabs
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