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REMEL EUROPE LIMITED · Model R30859602 · UDI-DI 05056080500997

GTJ
1
510(k) clearances
1
Adverse events
5
Recalls
2
Facilities

Recalls

DateFirmReason
2026-07-17Remel Europe Ltd.Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
2007-09-06BD Diagnostic Systems / Lee LaboratoriesExhibits cross reactivity with Neisseria meningitides Group W135.
2007-09-06BD Diagnostic Systems / Lee LaboratoriesExhibits cross reactivity with Neisseria meningitides Group W135.
2007-09-06BD Diagnostic Systems / Lee LaboratoriesExhibits cross reactivity with Neisseria meningitides Group W135
2007-09-06BD Diagnostic Systems / Lee LaboratoriesExhibits cross reactivity with Neisseria meningitides Group W135

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.