Antisera, All Groups, N. Meningitidis
Microbiology · 21 CFR 866.3390
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
5 recall events for this product code
- Remel Europe Ltd.Open, ClassifiedAug 7, 2026
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
Z-2927-2026 · View FDA record ↗ - BD Diagnostic Systems / Lee LaboratoriesTerminatedAug 8, 2008
BD DifcoTM Neisseria Meningitidis Antisera Group Y, 228811, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton Dic
Exhibits cross reactivity with Neisseria meningitides Group W135.
Z-1559-2008 · View FDA record ↗ - BD Diagnostic Systems / Lee LaboratoriesTerminatedAug 8, 2008
BD DifcoTM Neisseria Meningitidis Antisera Group Y 228811, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dick
Exhibits cross reactivity with Neisseria meningitides Group W135.
Z-1560-2008 · View FDA record ↗ - BD Diagnostic Systems / Lee LaboratoriesTerminatedAug 8, 2008
BD DifcoTM Neisseria Meningitidis Antisera Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dick
Exhibits cross reactivity with Neisseria meningitides Group W135
Z-1561-2008 · View FDA record ↗ - BD Diagnostic Systems / Lee LaboratoriesTerminatedAug 8, 2008
BD DifcoTM Neisseria Meningitidis Antiserum Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dic
Exhibits cross reactivity with Neisseria meningitides Group W135
Z-1562-2008 · View FDA record ↗
Registered firms
7 firms currently registered for this product code
510(k) clearances
16 clearances for this product code
- Bd Becton Dickinson Vacutainer Systems PreanalyticMay 30, 1996
K952791 · DIRECTIGEN MENINGITIS COMBO TEST
- Bd Becton Dickinson Vacutainer Systems PreanalyticMar 23, 1992
K915330 · DIRECTIGEN MENINGITIS COMBO TEST KIT
- Vitek Systems, Inc.Aug 12, 1991
K910210 · SLIDEX MENINGITE-KIT 5
- Armkel, LLCFeb 7, 1989
K885004 · BACTIGEN(R) N. MENINGITIDIS
- Microscan Div. Baxter Healthcare Corp.Mar 17, 1987
K870089 · IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT
- Wellcome DiagnosticsFeb 4, 1986
K854851 · WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24
- Wellcome DiagnosticsFeb 4, 1986
K854852 · WELLCOGEN BACTERIAL ANTIGEN KIT
- Pharmacia, Inc.Oct 17, 1985
K844999 · PHADEBACT CSF TEST