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Dutch inspectorate flags premature vacuum tubing wear in Hitachi cobas c 303 analytical unit

🇳🇱 IGJ · Sun 08 Nov 2026

IGJ has published a manufacturer field safety notice after complaints that vacuum tubing in the cell rinse unit of the cobas c 303 deteriorated earlier than expected.

The Dutch Health and Youth Care Inspectorate (IGJ) has published a manufacturer warning concerning the cobas c 303 analytical unit, made by Hitachi High-Tech Corporation. The notice states that complaints have been received about vacuum tubing in the unit's cell rinse unit deteriorating prematurely.

The field safety notice (FSN) from the manufacturer is dated 29 October 2026, and the IGJ listing carries a date of 9 November 2026. Roche Diagnostics GmbH is named as the authorised representative. The IGJ page links to a three-page PDF of the notice in English.

The IGJ summary does not describe any corrective action, the units or serial ranges affected, or any impact on patients or test results. Laboratories using the analyser will need to consult the full manufacturer notice for those details.

As general context, manufacturers are required to monitor devices after they reach the market and to act when a risk to users arises. They inform users and the inspectorate of such action through a field safety notice.

What it means for your team

  • Laboratories operating the cobas c 303 should obtain and read the full FSN to establish what action, if any, is required for their instruments.
  • Quality and vigilance teams should check whether the notice has been received, logged and assessed under their internal field safety corrective action procedures.
  • The public IGJ item gives no information on affected units or patient impact, so these points should not be assumed and should be confirmed with the manufacturer or Roche Diagnostics.

Official source: IGJ ↗

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

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