The FDA issued a warning to consumers on Thursday over potential bacteria contamination affecting certain Covid-19 at-home tests.
Consumers and health care workers are advised "to stop using and toss out certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics."
Recall Notice - SD Biosensor, Inc. Requests Discontinuation of Use and Disposal of Specific Pilot™ COVID-19 At-Home Tests in the United States Due to Microbial Contamination in the Liquid Buffer Solution https://t.co/xb6GXGrOv8 pic.twitter.com/Ub9evKKHaJ
— U.S. FDA Recalls (@FDArecalls) May 5, 2023
According to the FDA, the agency has "significant concerns of bacterial contamination" in the liquid solution component of the kits. "Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test," said the agency, issuing a "do not use" warning to consumers.
The contamination could have come from raw materials from a supplier, according to SD Biosensor.
Specifically, the tests could be contaminated with Enterococcus, Enterobacter, Klebsiella, and Serratia bacterial species - the infection of which could cause illness in individuals with weakened immune systems, or those who have direct exposure to the contaminated liquid test solution via misuse, accidental spills, or “standard handling” of the product, the Epoch Times reports. --->READ MORE HERE
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| News Nine |
A Melbourne mom being denied a lifesaving transplant under a “no jab, no heart” policy has accused the hospital of “ideological” discrimination for refusing the COVID vaccine.
Vicki Derderian, 47, has been on mechanical life support since 2020 after her heart failed and is desperate for a transplant, but The Alfred Hospital deemed her ineligible to be placed on the organ donor waiting list because she is not vaccinated against COVID.
“I think it’s a form of punishment,” she said.
“They’re set in their ways — basically it’s ‘no jab, no heart’. There is no long-term study on the efficacy of vaccines on pre- and post-transplant patients. I have a legal exemption from ATAGI which they are refusing to acknowledge.”
Despite widespread public attention on her case, Alfred Health is refusing to budge, offering only to meet with Derderian to discuss her “vaccination concerns”.
The mother-of-two suffers from a rare auto-immune disorder called sarcoidosis and is concerned about the risk of heart conditions such as myocarditis or pericarditis associated with the Pfizer and Moderna mRNA vaccines.
Myocarditis, inflammation of the heart, is a known but rare side effect of the mRNA vaccines, reported in around two out of every 100,000 people but more commonly among boys and young men.
Derderian is challenging Alfred Health’s decision in the Victorian Civil and Administrative Tribunal (VCAT), alleging discrimination under the Equal Opportunity Act 2010. --->READ MORE HEREFollow links below to relevant/related stories and resources:
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