Quality & complianceOfficial

BfArM publishes bioMérieux urgent field safety notice for eMAG laboratory system

🇩🇪 BfArM field safety notices · Wed 28 Oct 2026

Germany's regulator has posted a manufacturer advisory on the eMAG in-vitro diagnostic system; the specifics of the issue sit in an attached PDF.

The German Federal Institute for Drugs and Medical Devices (BfArM) has published an Urgent Field Safety Notice from bioMérieux, based in Marcy-l'Etoile, concerning the company's eMAG system. The entry is dated 28 October 2026 and carries the reference 43396/26.

BfArM classifies the product under in-vitro diagnostics, specifically instruments, apparatuses and systems. The web entry itself gives no description of the problem, the affected lots or serial numbers, or the corrective steps users are asked to take.

Instead, the regulator directs readers to the manufacturer's Advisory Notice, attached as a 496 KB PDF. All details on the device and on the required actions are in that document, which was not reproduced in the BfArM text available to VigiEye.

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 medical device. National authorities such as BfArM often publish these notices on their websites.

What it means for your team

  • Laboratories using the bioMérieux eMAG system should download and read the full Advisory Notice (reference 43396/26) to establish whether they are affected.
  • Quality and regulatory teams should confirm any actions the manufacturer requires and keep a record of the response in their quality system.
  • The BfArM entry does not state the nature of the issue or the scope, so no conclusions should be drawn until the manufacturer's document has been reviewed.

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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