Quality & complianceOfficial

Remel Europe warns of underperforming Neisseria meningitidis Group C reagent lots

🇳🇱 IGJ · Thu 12 Nov 2026

A technical investigation prompted by a customer complaint found certain lots of Remel's R30166901 reagent fail to react with the ATCC13102 control strain within the 60 seconds set in the instructions for use.

Remel Europe Ltd has issued a field safety notice after finding that certain lots of its Neisseria meningitidis Gp C 2ml/vial reagent, product code R30166901, are not performing to the criteria in the instructions for use (IFU). The Dutch healthcare inspectorate IGJ published the manufacturer's warning on its website.

According to the notice, a technical investigation was launched following a customer complaint. It determined that the affected lots do not give a positive reaction with the ATCC13102 strain within 60 seconds, as the IFU requires.

The field safety notice is dated 12 August 2026. The authorised representative named in the notice is Thermo Fisher Diagnostics B.V. IGJ's English-language PDF of the warning runs to six pages. The source text does not list the affected lot numbers, so users need to consult the full notice for those details.

The summary on file says the shortfall could lead to unreliable laboratory identification results. The notice is a manufacturer's warning rather than an action by the inspectorate.

What it means for your team

  • Laboratories using R30166901 should check their stock against the lot numbers listed in the full field safety notice.
  • Quality teams should review the notice for the manufacturer's instructions and record any actions taken, since the source text here does not set out corrective measures.
  • Manufacturers and authorised representatives should note that a customer complaint led to this investigation, a reminder of post-market surveillance obligations for medical devices.

Official source: IGJ ↗

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

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