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BfArM publishes Beckman Coulter urgent field safety notice for COULTER DxH Diluent

🇩🇪 BfArM field safety notices · Mon 09 Nov 2026

Germany's regulator has posted a manufacturer advisory on the haematology reagent, but the defect and required user actions appear only in the attached Beckman Coulter notice.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice from Beckman Coulter, Inc. on 9 November 2026. It concerns COULTER DxH Diluent, a reagent used with DxH haematology analysers. The entry is filed under reference 52067/26 in the product group of in-vitro diagnostics covering haematological, histological and cytological products.

The BfArM listing itself gives no details of the problem. It does not describe the nature of the defect, the affected lots or the actions users are asked to take. It refers readers to the manufacturer's Advisory Notice, which is attached as a 423 KB PDF.

Without the content of that document, it is not possible to say what the issue is, how many laboratories may be affected or how urgent the corrective measures are. Laboratories using the diluent should consult the full advisory directly.

What it means for your team

  • Laboratories running DxH analysers should download and read the Beckman Coulter Advisory Notice to check whether their diluent lots or instruments are affected.
  • Quality and regulatory teams should log the notice under BfArM reference 52067/26 and document any follow-up actions in line with their field safety corrective action procedures.
  • The BfArM description does not state the defect or required actions, so internal assessments should rely on the manufacturer's document rather than the listing.

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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