FDA Warns Abbott COVID-19 Test May Return False Negatives

The US FDA issued an alert cautioning the public that Abbott’s widely used rapid test for detecting coronavirus has been linked to false-negative results.

Abbott-sign

The US Food and Drug Administration issued an alert on 14 May warning the public of "possible accuracy concerns" with Abbott Laboratories Inc.’s ID NOW point-of-care test, used by hospitals nationwide to test for COVID-19.

The agency said it received 15 adverse event reports about the ID NOW COVID-19 test, suggesting some users are receiving...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

More from Policy & Regulation

MDUFA VI Launches With Public Meeting, Call For Comments

 
• By 

Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.

Permanent FDA Top Lawyer Expected After HHS Counsel Confirmation

 
• By 

Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.

FDA Drops Package Labeling Guidance For Hernia Mesh Manufacturers

 

The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.