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Dutch inspectorate flags Roche cobas calibration software defect affecting Spline-type assays

🇳🇱 IGJ · Sun 01 Nov 2026

IGJ has published a manufacturer's field safety notice on a software malfunction that lets cobas pro and cobas pure analysers accept erroneous calibrations.

The Dutch Health and Youth Care Inspectorate (IGJ) has published a manufacturer warning about a software malfunction in the Calibration Library of the cobas pro (c503) and cobas pure (c303) platforms. The listing is dated 2 November 2026.

According to the notice, the defect allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. The source does not describe how often this occurs, which assays are involved or whether any patient impact has been reported.

The manufacturer named in the IGJ entry is Hitachi High-Technologies Corporation, with Roche Diagnostics GmbH listed as authorised representative. The product is described as a sample supply unit, and the field safety notice (FSN) is dated 10 July 2026. A five-page English PDF of the warning is available for download from the inspectorate.

IGJ notes that manufacturers must monitor devices after they are placed on the market and improve them where necessary. Where a risk to users arises, they must act and inform users and the inspectorate through a field safety notice. The IGJ entry itself does not set out corrective actions, which are contained in the notice.

What it means for your team

  • Laboratories using cobas pro (c503) or cobas pure (c303) analysers should obtain and review the full field safety notice for the required actions.
  • Quality teams should check whether Spline-type assays are used on the affected platforms and how calibration acceptance is currently verified.
  • Regulatory and vigilance staff should record the FSN, dated 10 July 2026, in their field action tracking and confirm that internal communication has taken place.

Official source: IGJ ↗

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

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