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BfArM publishes urgent field safety notice for BioFire FilmArray Torch system

🇩🇪 BfArM field safety notices · Thu 22 Oct 2026

Germany's BfArM has listed a manufacturer safety notice for BioFire Diagnostics' FilmArray Torch, but the listing gives no details of the issue or the actions required.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice from BioFire Diagnostics, LLC on 22 October 2026. It covers the BIOFIRE FILMARRAY TORCH system and is listed under reference 46152/26.

BfArM classes the product group as in-vitro diagnostics, specifically equipment and products for clinical chemistry.

The listing does not describe the problem, the affected devices or any corrective action. It refers readers to the manufacturer's Advisory Notice, which is attached as a PDF of about 430KB. Details on scope, risk and instructions to users are therefore only in that document.

As general context, a field safety notice is the communication a manufacturer sends to customers when it takes a field safety corrective action on a marketed device. Regulators such as BfArM publish these notices so that users and healthcare facilities can check whether they are affected.

What it means for your team

  • Laboratories and hospitals using the BIOFIRE FILMARRAY TORCH should obtain and read the full manufacturer Advisory Notice to confirm whether their devices are affected.
  • Device-vigilance and quality teams should check whether the manufacturer has already sent the notice directly and record it in their field-action tracking.
  • The BfArM listing alone does not support conclusions on severity or required actions; wait for the details in the Advisory Notice.

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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