Quality & complianceOfficial

BfArM publishes urgent field safety notice for Zytomed Systems' Rabbit anti-TFE3 reagent

🇩🇪 BfArM field safety notices · Wed 28 Oct 2026

The German regulator has listed a manufacturer field safety notice for an in-vitro diagnostic antibody product, but the public entry gives no detail on the problem or required action.

The German Federal Institute for Drugs and Medical Devices (BfArM) has published an Urgent Field Safety Notice from Zytomed Systems GmbH covering its Rabbit anti-TFE3 product. The entry is dated 28 October 2026 and carries the reference 48998/26.

BfArM classifies the product under in-vitro diagnostics, specifically haematological, histological and cytological products. The summary describes Rabbit anti-TFE3 as an antibody reagent.

The BfArM listing does not describe the issue behind the notice, the batches or devices affected, or the corrective action requested. It states only that further information and device details are in the manufacturer's Advisory Notice, which is attached as a 124KB PDF.

As general context, a field safety notice is the communication a manufacturer sends to customers when it takes a field safety corrective action for a device on the market. Regulators such as BfArM publish these notices so users can find them.

What it means for your team

  • Quality and laboratory teams should download and read the Zytomed Advisory Notice (reference 48998/26) to learn the nature of the issue and the action required.
  • Check inventory and ongoing use for Rabbit anti-TFE3 from Zytomed Systems GmbH, and identify any affected product once the notice specifies it.
  • Do not infer the scope or severity of the problem from the BfArM listing, which contains no such detail.

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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