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BfArM publishes urgent field safety notice for Ion Torrent Genexus Dx software

🇩🇪 BfArM field safety notices · Fri 06 Nov 2026

Germany's regulator has posted a manufacturer notice from Life Technologies Holdings concerning software for the Ion Torrent Genexus Dx, but the public listing gives no detail of the problem.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an urgent field safety notice on 6 November 2026 relating to the software of the Ion Torrent Genexus Dx. The notice comes from Life Technologies Holdings Pte Ltd.

BfArM lists the item under in-vitro diagnostics, in the product group for instruments, apparatuses and systems, with reference number 51601/26. The listing itself does not describe the nature of the software issue, the affected versions or the corrective measures.

Instead, BfArM directs readers to the manufacturer's Advisory Notice, which is attached to the entry as a 719 KB PDF. The regulator's page says that document contains further information and details about the device. The file is flagged as not meeting accessibility standards.

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 marketed medical device. Regulators such as BfArM make these notices publicly available.

What it means for your team

  • Laboratories using the Ion Torrent Genexus Dx should obtain and read the full Advisory Notice via the BfArM entry (reference 51601/26) to establish whether and how they are affected.
  • Quality and regulatory teams should check that the notice has been logged in their field action and vigilance records, and that any actions requested by the manufacturer are tracked to completion.
  • The BfArM listing does not specify the issue or required actions, so no assessment of risk or impact can be made from the public summary alone.

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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