2. >>Policy & Regulation

Abbott Recalls Freestyle InsuLinx Glucose Meter Following Similar J&J Recall

Abbott initiates a global recall of its FreeStyle InsuLinx blood glucose meter, after a similar recall of J&J/LifeScan glucose meter, due to device’s inaccurate reading at high blood glucose levels.

Abbott Laboratories Inc. initiated a global recall of its FreeStyle InsuLinx blood glucose meter on April 15 following a similar recall of a blood glucose meter by Johnson & Johnson/LifeScan Inc. in late March.

LifeScan recalled its OneTouchVerio IQ blood glucose meter March 25 due to the meter shutting down when it reached a reading of 1,024 mg/dL or above

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 Regulation

More from Policy & Regulation

Access To Library Tools Being Restored At US FDA

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals and laid off librarians have not been reinstated.

FDA Announces Classifications On 9 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.