1. Medtech Insight
  2. >>Archive

Alere recalls 800,000 Triage tests on quality control issues

 
• By Madeleine Armstrong

Alere has recalled 803,000 of its Triage tests after problems with quality control testing and performance of the diagnostics. The recall affects a total of 104 lots comprising 287,000 Alere Triage BNP (B-type natriuretic peptide) tests, 46,000 Alere Triage D-dimer tests and 470,000 Alere Triage cardiology panel tests, according to a company filing with the US Securities and Exchange Commission (SEC).

Alere has recalled 803,000 of its Triage tests after problems with quality control testing and performance of the diagnostics. The recall affects a total of 104 lots comprising 287,000 Alere Triage BNP (B-type natriuretic peptide) tests, 46,000 Alere Triage D-dimer tests and 470,000 Alere Triage cardiology panel tests, according to a company filing with the US Securities and Exchange Commission (SEC).

It looks like the company will also have to recall its Alere Triage TOX Drug Screen test: it said it...

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
Start Free Trial

Already a subscriber?

More from Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Ryan Nelson

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By Marion Webb

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

More from Medtech Insight

International Reliance Gets UK MHRA OK In Drive For Agile Pre-Market Regulation – CE Marking Next

 
• By Ashley Yeo

The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.

Opinion: Catch A Fraudulent Scientist -- If You Can

 
• By Ivor Campbell

As AI tools make research fraud and résumé fraud easier than ever, life sciences companies need to take steps to protect themselves. Snedden Campbell CEO Ivor Campbell has some tips on successful strategies.

Medtronic’s MiniMed Expands EU Uses Of MiniMed 780G And Readies For US Expansion Amid Competition

 
• By Shubham Singh

The timing aligns with Medtronic’s plan to spin off its $2.8bn diabetes unit, now named MiniMed. As a standalone entity, MiniMed will be more responsive to competition, regulatory shifts, and the diabetes technology needs of healthcare systems.