Millions of COVID-19 home testing kits recalled in USA

Millions of COVID-19 home testing kits recalled in USA.
ಹ್ಯಾರಿ ಜಾನ್ಸನ್ ಅವರ ಅವತಾರ
ಇವರಿಂದ ಬರೆಯಲ್ಪಟ್ಟಿದೆ ಹ್ಯಾರಿ ಜಾನ್ಸನ್

Some 2,212,335 kits produced by the Australian-based biotech company Ellume and distributed in the US potentially show false positive SARS-CoV-2 test results.

  • US Federal Food and Drug Administration issues an urgent recall of faulty COVID-19 home testing kits.
  • Recalled home testing kits show ‘higher-than-acceptable’ false positive COVID-19 results.
  • The test which detects coronavirus proteins, was authorized for emergency use by the FDA last year.

A ‘Class I recall’ for millions of popular rapid COVID-19 home testing kits has been issued by the US Federal Food and Drug Administration (FDA).

ರ ಪ್ರಕಾರ ಎಫ್ಡಿಎ, ‘the most serious type of recall’ was issued due to 2,212,335 COVID-19 test kits produced by the Australian-based biotech firm ಎಲ್ಯುಮ್, and distributed in the US, show ‘higher-than-acceptable’ false positive SARS-CoV-2 test results.

The US federal regulator warned that the use of faulty kits “may cause serious adverse health consequences or death.” 

The antigen test, which detects coronavirus proteins, was authorized for emergency use by the FDA last year. It is available without a prescription for both adults and children aged two and older, and uses swab samples taken from a nose to detect if one has COVID-19.

Some “specific lots,” manufactured between February and August this year, are now being recalled in the US, with the company saying it has worked with the authorities to voluntarily remove the affected tests from the market.

The company has offered its apologies “for any stress or difficulties [customers] may have experienced because of a false positive result.” 

The ‘higher-than-acceptable’ false results, showing that a person has coronavirus when in reality they do not, have been reported to the FDA in at least 35 cases. No false negative results have been detected.

However, the inaccurate diagnostic could have life-threatening consequences. A person might receive wrong or unnecessary treatment, including with antiviral and antibody therapy, and suffer additional trauma over having to isolate from family members and friends.

It might also lead to people disregarding precautions, including getting vaccinated against COVID-19, the FDA has said.

ಲೇಖಕರ ಬಗ್ಗೆ

ಹ್ಯಾರಿ ಜಾನ್ಸನ್ ಅವರ ಅವತಾರ

ಹ್ಯಾರಿ ಜಾನ್ಸನ್

ಹ್ಯಾರಿ ಜಾನ್ಸನ್ ಅಸೈನ್‌ಮೆಂಟ್ ಎಡಿಟರ್ ಆಗಿದ್ದಾರೆ eTurboNews 20 ವರ್ಷಗಳಿಗಿಂತ ಹೆಚ್ಚು ಕಾಲ. ಅವರು ಹೊನೊಲುಲು, ಹವಾಯಿಯಲ್ಲಿ ವಾಸಿಸುತ್ತಿದ್ದಾರೆ ಮತ್ತು ಮೂಲತಃ ಯುರೋಪಿನವರು. ಅವರು ಸುದ್ದಿ ಬರೆಯಲು ಮತ್ತು ಕವರ್ ಮಾಡಲು ಇಷ್ಟಪಡುತ್ತಾರೆ.

ಚಂದಾದಾರರಾಗಿ
ಸೂಚಿಸಿ
ಅತಿಥಿ
0 ಪ್ರತಿಕ್ರಿಯೆಗಳು
ಇನ್ಲೈನ್ ​​ಪ್ರತಿಕ್ರಿಯೆಗಳು
ಎಲ್ಲಾ ಕಾಮೆಂಟ್‌ಗಳನ್ನು ವೀಕ್ಷಿಸಿ
0
ನಿಮ್ಮ ಆಲೋಚನೆಗಳನ್ನು ಇಷ್ಟಪಡುತ್ತೀರಾ, ದಯವಿಟ್ಟು ಕಾಮೆಂಟ್ ಮಾಡಿ.x
ಶೇರ್ ಮಾಡಿ...