RegulatoryOfficial

IGJ posts bioMérieux notice on EMAG 'Error 10003' heating element time-out

🇳🇱 IGJ · Sun 01 Nov 2026

The Dutch health inspectorate has published a manufacturer field safety notice on a heating element time-out error affecting bioMérieux EMAG systems already running the SP4 Patch version 2.

The Dutch Health and Youth Care Inspectorate (IGJ) has published a field safety notice from bioMérieux SA covering the EMAG system, reference 418591/418591U. The notice is dated 12 October 2026.

According to the IGJ listing, the notice informs users about the error message 'Error 10003'. The fault is linked to a time-out problem of the heating element while the EMAG system is in use. The notice concerns systems on which SP4 Patch version 2 was previously implemented.

The published text does not describe the root cause, the affected serial numbers or lots, the risk assessment or any corrective action requested of users. Those details may be in the three-page PDF attached to the IGJ page, which was not available for this report.

The IGJ repeats its standard explanation that manufacturers must monitor devices after they reach the market and take action where users face a risk. They inform users and the inspectorate of that action through a field safety notice.

What it means for your team

  • Laboratories using EMAG systems (ref. 418591/418591U) should read the full bioMérieux notice for the required actions, as the IGJ summary does not state them.
  • Quality teams should check whether their instruments run SP4 Patch version 2, since the notice refers to systems on which it was implemented.
  • Vigilance and quality staff should log any 'Error 10003' events and follow the manufacturer's instructions and local incident-reporting procedures.

Official source: IGJ ↗

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

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