Quality & complianceOfficial

BfArM publishes urgent field safety notice for RAL Stainer and RAL TB Stainer devices

🇩🇪 BfArM field safety notices · Wed 04 Nov 2026

The German regulator has listed an urgent field safety notice from RAL Diagnostics for two laboratory staining instruments; details sit in the manufacturer's Advisory Notice.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice from RAL Diagnostics on 4 November 2026. It covers the RAL Stainer and the RAL TB Stainer.

BfArM classifies the notice under in-vitro diagnostics, in the group of instruments, apparatuses and systems. It is listed under reference 46445/26.

The BfArM entry does not describe the problem with the devices, the affected units or the actions users should take. It directs readers to the manufacturer's Advisory Notice, attached as a 588 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 for a medical device, including in-vitro diagnostic devices. Competent authorities such as BfArM typically publish these notices for transparency.

What it means for your team

  • Laboratories using the RAL Stainer or RAL TB Stainer should obtain and read the manufacturer's Advisory Notice via the BfArM listing, as the regulator's page gives no details of the issue or required actions.
  • Quality and vigilance teams should check whether any affected instruments are in their inventory and record the notice under reference 46445/26 in their field action tracking.
  • Distributors and service organisations handling these instruments should confirm they have received the notice directly from RAL Diagnostics.

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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