October 20, 2021

Medical Trend

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Australia Elum Company recalled 200K COVID-19 test kits it sold to U.S.

Australia Elum Company recalled 200K COVID-19 test kits it sold to U.S.



 

Australia Elum Company recalled 200K COVID-19 test kits it sold to U.S. and detected “false positives” due to quality problems, and hundreds of thousands have been recalled!


According to a report from “Russia Today” (RT) on the 5th, Australia’s Elum Company recalled 200,000 COVID-19 test kits it sold to the United States. The reason is that these test kits have quality problems and may have false positive results.

 

Australia Elum Company recalled 200K COVID-19 test kits it sold to U.S.

RT report chart RT report chart

 

According to reports, the U.S. Food and Drug Administration (FDA) issued a notice on the 5th to remind the public that some of Elum’s household test kits “may have false positive results.” According to the report, this is a rapid antigen test that uses nasal swabs and mobile phone applications to detect the COVID-19.

 

The FDA said it is “closely cooperating” with Elum to evaluate future “corrective steps.” In addition, the FDA requires those who have used the Elum test kit and get a positive result to consult a doctor, and urges those who have purchased the problem test kit to replace it.

 

The report mentioned that Elum CEO stated that the company noticed the false positive results of specific product batches and identified the cause. However, the company refused to elaborate on the cause of the problem on the grounds of trade secrets.

 

“The increase in false positives is the result of problems with the supply chain of one of the test components,” Elum spokesperson said in a statement. “Because of the patent information involved in the manufacturing process, we are unable to provide more details.”

 

Although neither Elum nor the FDA provided the exact number of test boxes that were recalled, RT cited the New York Times as saying that the number of test boxes recalled by Elum was about 200,000. The New York Times stated that of the 427,000 test kits sold to the United States, half of them have been used, resulting in about 42,000 positive results. It is unclear how many of these positive cases are false.

 

 

 

 

(source:internet, reference only)


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