Remel Europe Neisseria meningitidis Gp C reagent lots fail performance criteria, Dutch inspectorate notes
A technical investigation prompted by a customer complaint found certain lots of Remel's 2ml Neisseria meningitidis Gp C reagent do not meet instructions-for-use performance criteria.
The Dutch Health and Youth Care Inspectorate (IGJ) has published a manufacturer field safety notice concerning Remel Europe Ltd's Neisseria meningitidis Gp C reagent, product R3066901, supplied in 2ml vials.
According to the notice, a technical investigation triggered by a customer complaint determined that certain lots are not performing to the criteria set out in the instructions for use. Specifically, the reagent does not give a positive result with the reference strain ATCC13102 within 60 seconds.
The manufacturer's field safety notice is dated 25 June 2026. Thermo Fisher Diagnostics B.V. is named as the authorised representative. The IGJ posting links to a seven-page English-language PDF of the notice, which carries the date 11-11-2026 in its title; the lot details and corrective instructions are contained in that document rather than in the web text.
The IGJ explains that manufacturers must monitor their devices after they reach the market and take action where users may be at risk, informing both users and the inspectorate through a field safety notice. The item falls under the inspectorate's oversight of medical technology.
What it means for your team
- Laboratories using Remel R3066901 should check their stock against the lot numbers listed in the full field safety notice and follow the manufacturer's corrective instructions.
- Quality teams may wish to review any recent Neisseria meningitidis Gp C results obtained with this reagent, in line with local procedures and the manufacturer's guidance.
- Distributors and authorised representatives should confirm that the notice has reached all affected customers and that actions are documented.
Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.
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