RegulatoryOfficial

bioMérieux warns EMAG users of 10003 Error heater time-out issue

🇳🇱 IGJ · Tue 10 Nov 2026

The Dutch health inspectorate has published a bioMérieux field safety notice on the EMAG system, covering references 418591 and 418591U.

The Dutch healthcare inspectorate, IGJ, has published a manufacturer warning from bioMérieux SA about its EMAG® system. The notice concerns a "10003 Error" heater time-out that can occur when the instrument is in use.

The warning applies to EMAG® references 418591 and 418591U. The manufacturer's field safety notice (FSN) is dated 16 September 2026, and the IGJ page carries the date 11 November 2026. The accompanying PDF is a six-page document available in English.

The IGJ summary says the purpose of the communication is to inform users of the heater time-out problem. The text available here does not describe the cause, the number of affected devices or the corrective actions, which are set out in the manufacturer's full notice.

The IGJ notes that manufacturers must monitor medical devices after they reach the market and improve them where needed. When a risk to users arises, the manufacturer must act and inform both users and the inspectorate through a field safety notice.

What it means for your team

  • Laboratories using EMAG® 418591 or 418591U should read the full bioMérieux FSN and follow any instructions it contains.
  • Quality teams should check whether 10003 Error events have been logged and whether their records and complaint files reflect them.
  • The source text does not describe the cause or corrective action, so teams should rely on the manufacturer's PDF rather than the IGJ summary.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

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