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Fisher Diagnostics recalls Infinity Ammonia Standard Set over low calibration bias of up to 15%

🇳🇱 IGJ · Sun 08 Nov 2026

The manufacturer has begun a field safety corrective action after customers reported ammonia calibration results roughly 6% to 15% too low following a switch of standard lots.

Fisher Diagnostics has started a field safety corrective action for its Infinity™ Ammonia Standard Set, according to a notice published by the Dutch health inspectorate IGJ. The manufacturer's field safety notice is dated 20 October 2026, and the IGJ posting carries a date of 9 November 2026.

The company said it received customer complaints describing a low calibration bias of approximately 6% to 15% after labs switched ammonia standard lots. Customers attributed the bias to the calibrators. The action applies to customers who bought the product listed in Table 1 of the notice, which is not reproduced in the IGJ summary.

Fisher Diagnostics warned that the issue may lead to prognostic misclassification for mortality thresholds, delays in starting time-sensitive treatment, and errors in clinical treatment decisions. The company said these outcomes could cause serious patient harm.

The authorised representative is WMDE B.V. The IGJ page links to a four-page English-language PDF of the notice. The text available here does not set out the root cause or the specific corrective steps, so affected users need to consult the full notice for the actions required.

As general context, manufacturers of medical devices, including in vitro diagnostics, must monitor products after they reach the market and act when a risk to users emerges. They inform users and the competent authority through a field safety notice.

What it means for your team

  • Laboratories using the Infinity Ammonia Standard Set should check whether their lots are listed in Table 1 of the field safety notice and follow its instructions.
  • Quality teams may wish to review recent ammonia calibration records and any lot changes for signs of low bias, as described in the notice.
  • Regulatory and vigilance staff should confirm that the notice has been received and actioned, and note the stated risk of serious patient harm.
  • The IGJ summary does not state the root cause or the corrective measures, so the full PDF is the authoritative source.

Official source: IGJ ↗

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

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