Wednesday, May 31, 2023
Khmer Daily Cambodia News
34 °c
Phnom Penh
  • LATEST
  • CAMBODIA
  • ASIA
    • JAPAN
    • SOUTH KOREA
    • TAIWAN
  • WORLD
    • CHINA
    • RUSSIA
  • BUSINESS CAMBODIA
  • TECHNOLOGY
No Result
View All Result
  • LATEST
  • CAMBODIA
  • ASIA
    • JAPAN
    • SOUTH KOREA
    • TAIWAN
  • WORLD
    • CHINA
    • RUSSIA
  • BUSINESS CAMBODIA
  • TECHNOLOGY
No Result
View All Result
The Khmer Daily
No Result
View All Result
Home World

FDA issues warning against using certain unauthorised Covid-19 ART kits from SD Biosensor

March 5, 2022
in Health, Lifestyle, World
0
FDA issues warning against using certain unauthorised Covid-19 ART kits from SD Biosensor
0
SHARES
3
VIEWS
Share on FacebookShare on Twitter

The US Food and Drug Administration (FDA) issued an advisory warning people not to use the SD Biosensor Inc. Standard Q Covid-19 Ag Home Test on Tuesday (March 1).

Antigen rapid test (ART) kits from SD Biosensor are sold in Singapore.

On its website, the FDA explained that it is concerned about the risk of false results when using this test. It is also not authorised, cleared, or approved by the FDA for distribution or use in the United States. This unauthorised test may be packaged in a white and magenta box (see image above).

The agency added that it has not received reports of injuries, adverse health consequences, or death associated with the use of this test.

Those who’ve used the test kit and suspect an inaccurate result are advised to speak to their healthcare providers, said FDA, an agency within the US Department of Health and Human Services.

It said that it is working with SD Biosensor Inc., a global in-vitro diagnostics company, to resolve this safety issue.

However, the agency added that a separate product, the SD Biosensor COVID-19 At-Home Test, was authorised by the FDA on Dec 24, 2021 and it is “not the subject of this safety communication.” This authorised test is distributed by Roche and can still be used.

SD Biosensor, Inc. has initiated a recall for all unauthorised SD Biosensor STANDARD Q COVID-19 Ag Home Tests that were distributed in the US.

Professor Paul Tambyah, president of the Asia-Pacific Society of Clinical Microbiology and Infection, told AsiaOne on Friday that “as far as we know, this [FDA advisory] does not apply to the kits distributed in Singapore which fall under the US FDA’s Emergency Use Authorisation (EUA).

He added that supplies in Singapore have been authorised by the Health Sciences Authority (HSA) and that “we should not stop using them”.

AsiaOne has contacted HSA, the national regulator of health products in Singapore, for comments.

This article was first published in Asia One . All contents and images are copyright to their respective owners and sources.

Tags: #coronavirus#COVID-19#Covid-19 Omicron variant#Covid-19 Testing#fda#US Food and Drug AdministrationSD Biosensor
Previous Post

Russia-Ukraine conflict, Fed hike to upset Turkish economy

Next Post

Toyota suspends operations in Russia

Related Posts

Trump vows to end birthright citizenship for children of immigrants in US illegally

Trump vows to end birthright citizenship for children of immigrants in US illegally

by AsiaOne
May 31, 2023
0
0

WASHINGTON — Donald Trump said on Tuesday (May 30) that if elected president again in 2024 he would seek to...

Deepfaking it: America’s 2024 election collides with AI boom

Deepfaking it: America’s 2024 election collides with AI boom

by AsiaOne
May 31, 2023
0
0

"I actually like Ron DeSantis a lot," Hillary Clinton reveals in a surprise online endorsement video. "He's just the kind...

Italy bets on quietest of places to host world-leading telescope

Italy bets on quietest of places to host world-leading telescope

by AsiaOne
May 31, 2023
0
0

LULA, Italy — Italy is proposing a disused mineral mine in a remote corner of Sardinia to house one of...

Most Popular

2 Chinese tourists’ naked bodies found in Bali hotel

2 Chinese tourists’ naked bodies found in Bali hotel

May 6, 2023
221
Oriental Bank Plc, new commercial bank in Cambodia, to enter market ventured by G Capital Bhd, Public Bank Bhd, E S Packaging

Oriental Bank Plc, new commercial bank in Cambodia, to enter market ventured by G Capital Bhd, Public Bank Bhd, E S Packaging

December 12, 2020
3.6k
Harry takes a seat at coronation, but no balcony appearance

Harry takes a seat at coronation, but no balcony appearance

May 8, 2023
6
At least 146 dead, 150 injured in stampede during Halloween festivities in Seoul

At least 146 dead, 150 injured in stampede during Halloween festivities in Seoul

October 30, 2022
116
Dara Sakor International Airport in Koh Kong province of Cambodia delayed due to unfinished construction

Dara Sakor International Airport in Koh Kong province of Cambodia delayed due to unfinished construction

May 19, 2023
4
Korea’s wiring harness manufacturer starts production in Kampong Speu of Cambodia

Korea’s wiring harness manufacturer starts production in Kampong Speu of Cambodia

April 27, 2023
4

© 2020 By Khmer Daily News

No Result
View All Result
  • Home
  • Latest
  • Cambodia
  • ASIA
  • World
  • Business
  • Tech

© 2019 The Khmer Daily.

error: Content is protected !!