Quality & complianceOfficial

Siemens Healthineers flags excess sodium azide in tricyclic antidepressant calibrator control lot

🇳🇱 IGJ · Sun 01 Nov 2026

Siemens Healthineers says one production lot of its tox Serum Tricyclic Antidepressant Calibrator Control contains more sodium azide than specified, though it reports no effect on performance.

Siemens Healthineers has told users that a production lot of its tox Serum Tricyclic Antidepressant Calibrator Control contains sodium azide above the specified concentration. The Dutch healthcare inspectorate, IGJ, has published the manufacturer's field safety notice, dated 2 November 2026.

According to the notice, an internal investigation found the concentration is 0.2% once the calibrator has been reconstituted. Before reconstitution, the calibrators contain 3.2% sodium azide. The notice does not state here what the specified concentration should be.

Siemens says the higher level does not affect product performance, because sodium azide serves only as a preservative in the material. The text available does not set out the lot number, the number of units affected, or the corrective actions requested of users.

The manufacturer is Siemens Healthcare Diagnostics Inc, and its authorised representative is Siemens Healthcare Diagnostics Manufacturing Ltd. IGJ notes that manufacturers must monitor devices after they reach the market and take action where users may be at risk, informing users and the inspectorate through a field safety notice.

What it means for your team

  • Laboratories using this calibrator control should consult the full field safety notice (a three-page PDF on the IGJ site) to confirm whether their lot is affected.
  • Quality teams should check that any lot identification, handling instructions and records requested by the manufacturer are followed and documented.
  • The manufacturer states performance is unaffected, but the lot and action details were not available in the text reviewed, so teams should rely on the full notice.

Official source: IGJ ↗

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

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