Fisher Diagnostics issues field safety action for Infinity Ammonia Reagent on Beckman Coulter AU analysers
Customers reported ammonia results reading about 6% to 15% low after switching standard lots, with the manufacturer warning of possible serious patient harm.
Fisher Diagnostics has started a field safety corrective action for its Infinity Ammonia Reagent, used with Beckman Coulter AU Chemistry Analyzers. The Dutch health inspectorate IGJ has published the manufacturer's warning on its website.
According to the notice, the action follows customer complaints of a low calibration bias of roughly 6% to 15% after laboratories changed ammonia standard lots. The complainants attributed the bias to the calibrators. The issue applies to customers who bought the products listed in Table 1 of the notice.
The manufacturer says the problem may lead to prognostic misclassification for mortality thresholds, delays in starting time-sensitive treatment, and errors in clinical treatment decisions. It adds that these could result in serious patient harm.
The field safety notice is dated 27 October 2026. The authorised representative is B·R·A·H·M·S GmbH, part of Thermo Fisher Scientific. The IGJ page links to a six-page English PDF. The text available here does not describe the specific corrective steps customers are asked to take, so laboratories should consult the full document.
Under the EU medical device framework, manufacturers must monitor devices after they reach the market. Where a risk to users arises, they must act and inform both users and the competent authority through a field safety notice.
What it means for your team
- Laboratories using Infinity Ammonia Reagent on Beckman Coulter AU analysers should check Table 1 of the notice against their purchased products and follow the manufacturer's instructions.
- Quality teams may want to review recent ammonia calibrations, particularly those performed after a change of standard lot, and check how any affected results were used clinically.
- Vigilance and regulatory staff should keep the field safety notice and the IGJ publication on file as part of their field safety corrective action records.
Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.
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