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BfArM publishes urgent field safety notice for Helena Biosciences V8 UltraCE diagnostic device

🇩🇪 BfArM field safety notices · Fri 06 Nov 2026

Germany's regulator has posted a manufacturer notice for the V8 UltraCE, but its public description gives no detail on the problem, affected lots or required actions.

The German Federal Institute for Drugs and Medical Devices (BfArM) has published an Urgent Field Safety Notice from Helena Biosciences Europe covering the V8 UltraCE. The entry is dated 6 November 2026 and carries the reference 51119/26.

BfArM lists the device in the product group of in-vitro diagnostics, specifically haematological, histological and cytological products. Beyond that classification, the regulator's description does not set out the nature of the issue, the affected lots or serial numbers, or what users are being asked to do.

Instead, the entry directs readers to the manufacturer's Advisory Notice, which is attached as a 296KB PDF. BfArM flags that the file does not meet accessibility standards. Any substantive information about the field safety corrective action therefore sits in that document and not in the BfArM summary.

For 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 then make these notices publicly available.

What it means for your team

  • Laboratories and distributors that use or supply the V8 UltraCE should obtain and read the full Advisory Notice (reference 51119/26) to establish whether they are affected.
  • Quality teams should not rely on the BfArM web entry alone, since it states neither the issue, the scope nor the required actions.
  • Teams should check internal records for the device and confirm who receives and acts on manufacturer notices, so any actions in the PDF can be completed and documented.

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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