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BfArM lists Beckman Coulter urgent field safety notice for SW40 and SW41 rotor assemblies

🇩🇪 BfArM field safety notices · Thu 22 Oct 2026

Germany's regulator has published a manufacturer advisory covering two Beckman Coulter centrifuge rotor assemblies, though the listing itself gives no detail on the problem or the actions required.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 22 October 2026 from Beckman Coulter, Inc. It concerns the rotor assemblies ROTOR-BAUGRUPPE-SW40 and ROTOR-BAUGRUPPE-SW41.

BfArM files the notice under the product group of in-vitro diagnostics, covering instruments, apparatuses and systems, with the reference 44423/26. The entry directs readers to the manufacturer's Advisory Notice for further information and device details.

The public listing does not describe the defect, the potential risk, the affected serial numbers or lot ranges, or the corrective steps users are expected to take. Those details are in the Advisory Notice, which BfArM provides as a PDF of 299 KB. The agency notes that the file does not meet 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 publish these notices so that affected organisations can identify and act on them.

What it means for your team

  • Laboratories and other users of Beckman Coulter SW40 or SW41 rotor assemblies should read the full Advisory Notice to establish whether their units are affected.
  • Quality teams should check equipment inventories against the manufacturer's notice and record any actions taken, since the BfArM listing does not specify them.
  • Regulatory and vigilance staff should treat reference 44423/26 as the identifier for tracking this notice and should not infer the nature of the issue from the listing 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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