PharmacovigilanceOfficial

Helena Laboratories issues V8 UltraCE field safety notice over IFE diluent shortfall

🇳🇱 IGJ · Thu 05 Nov 2026

A manufacturer notice published by Dutch inspectorate IGJ describes how the analyser can place samples from two patients in one IFE block when diluent runs short.

The Dutch healthcare inspectorate IGJ has published a field safety notice (FSN) from Helena Laboratories UK Limited concerning its V8 UltraCE analyser. The FSN is dated 30 October 2026, and the authorised representative is listed as Advena Limited.

According to the notice, the analyser prepares six dilutions for each patient sample during automated IFE gel tray preparation: Total, IgG, IgA, IgM, Kappa and Lambda. The notice then addresses what happens when there is not enough IFE Diluent to complete all six, and the diluent is partly replaced by sample preparation.

In that situation, the remaining IFE strips can be prepared using the next patient's sample, provided five conditions are met. The notice states that this results in a single IFE block containing samples from two different patients.

The IGJ page does not set out the five conditions, and the text available does not describe any corrective action or report any adverse events. Those details are likely to be in the six-page PDF attached to the notice, which was not part of the material reviewed.

An FSN is the document through which a manufacturer informs users and the inspectorate of action taken after a device is on the market and a risk to users has been identified.

What it means for your team

  • Laboratories using the V8 UltraCE should obtain the full FSN from IGJ and check the five conditions and any required user actions.
  • Quality teams should assess how a block holding two patients' samples is identified and handled in their IFE workflow and result review.
  • Vigilance staff should check whether any related incidents have been recorded locally and whether the manufacturer's reporting expectations apply.
  • The corrective action is not stated in the available text, so teams should not assume what the manufacturer requires until they have read 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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