Quality & complianceOfficial

BfArM publishes Abbott field safety notice for FreeStyle Libre 3 App and Libre App

🇩🇪 BfArM field safety notices · Wed 28 Oct 2026

Germany's regulator has listed an Urgent Field Safety Notice from Abbott Diabetes Care Ltd. UK for two glucose-monitoring apps, but the entry itself gives no details of the issue.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 28 October 2026 from Abbott Diabetes Care Ltd. UK. It covers the FreeStyle Libre 3 App and the Libre App.

BfArM files the entry under reference 48233/26 and classes it in the product group 'Medical data processing (software) - medical apps'.

The public listing does not describe the problem, the affected software versions or the actions required of users. It refers readers to the manufacturer's Advisory Notice, attached as a 187 KB PDF, for further information and device details.

As general context, a field safety notice is the communication a manufacturer sends to users when it takes a field safety corrective action on a medical device already on the market. National authorities such as BfArM then publish these notices.

What it means for your team

  • Regulatory and quality teams handling these apps should obtain and read the manufacturer's Advisory Notice, as the BfArM page does not state the issue or the corrective actions.
  • Pharmacovigilance and vigilance staff should check whether any incident reports or complaints involving the apps need to be linked to this notice (reference 48233/26).
  • Teams should not draw conclusions about severity or scope until the Advisory Notice has been reviewed.

Official source: BfArM field safety notices ↗

Article written by VigiEye from the official source (BfArM field safety notices). AI-assisted; check the source before acting.

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