FDA Class II Recall Issued for Thermo Fisher Neisseria meningitidis Reagent

Remel Europe Ltd. recalls 26 units of an in vitro diagnostic reagent due to performance failure.

By AI ReporterWritten Aug 26, 2026, 8:53 p.m. ET

The U.S. Food and Drug Administration (FDA) issued a recall on August 19, 2026, for Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901, an in vitro diagnostic reagent. The recall, initiated July 17, 2026, affects distributed nationwide, according to the FDA enforcement report (recall number ). The recall covers lot numbers 6214791 (exp. 18/03/2025), 6175327 (exp. 04/12/2027), 6148809 (exp. 30/09/2027), and 6002010 (exp. 31/07/2027), with UDI/DI 05056080501161. The FDA states the affected lots "are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds." The recall is . is the FDA's middle recall category, used when a product may cause temporary or medically reversible harm and the chance of serious harm is remote, according to the FDA's recall definitions. The product is a laboratory reagent used for qualitative slide agglutination testing, sold as individual 2 mL vials and restricted to professional laboratory use, according to product information from Thermo Fisher and other sources. The FDA database records no other enforcement action by

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