Culture Media, For Isolation Of Pathogenic Neisseria
Microbiology · 21 CFR 866.2410
Recent MDR events
82 adverse event reports on file
- BD BBL¿ CHOCOLATE GC AGAR WITH ISOVITALEX¿Sep 30, 2025MalfunctionBecton Dickinson Gmbh9680577-2025-02914
- BD BBL¿ CHOCOLATE GC AGAR WITH ISOVITALEX¿Sep 30, 2025MalfunctionBecton Dickinson Gmbh9680577-2025-02915
- BD BBL¿ CHOCOLATE GC AGAR WITH ISOVITALEX¿Sep 30, 2025MalfunctionBecton Dickinson Gmbh9680577-2025-02916
- BD BBL¿ CHOCOLATE GC AGAR WITH ISOVITALEXSep 26, 2025MalfunctionBecton Dickinson Gmbh9680577-2025-02911
- BD BBL¿ CHOCOLATE GC AGAR WITH ISOVITALEXSep 26, 2025MalfunctionBecton Dickinson Gmbh9680577-2025-02913
- BD BBL¿ CHOCOLATE II AGARSep 4, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-04913
- BD BBL¿ CHOCOLATE II AGARSep 4, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-04914
- BD BBL¿ MARTIN-LEWIS AGARAug 29, 2025MalfunctionBecton Dickinson Gmbh9680577-2025-00340
- BD BBL¿ MARTIN-LEWIS AGARAug 29, 2025MalfunctionBecton Dickinson Gmbh9680577-2025-00337
- BD BBL¿ MARTIN-LEWIS AGARAug 29, 2025MalfunctionBecton Dickinson Gmbh9680577-2025-00338
Event type breakdown
Most-reported manufacturers
Recalls
9 recall events for this product code
- Remel, IncOpen, ClassifiedJun 30, 2026
GC Agar Base (150mm) 10/PK R04030;
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
Z-2623-2026 · View FDA record ↗ - Becton Dickinson & Co.Open, ClassifiedDec 9, 2022
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species.
Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for Haemophilus isolation in a clinical specimen.
Z-0473-2023 · View FDA record ↗ - Becton Dickinson & Co.TerminatedMay 3, 2013
BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gon
Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.
Z-1215-2013 · View FDA record ↗ - Becton Dickinson & CoTerminatedNov 27, 2003
Chocolate II Agar (GC II Agar with Hemoglobin and Iso Vitalex), microbiological media plates, Catalog #221267, packaged in cardboard carton, 100 plates per car
Microbiological media may exhibit reduced colony size of bacteria, Haemophilus species.
Z-0164-04 · View FDA record ↗ - Remel, IncTerminatedOct 24, 2003
Remel Thayer Martin Agar (Improved), packaged in 10-packs (Cat. #01884), 15-packs (Cat. #01885), and 100 per case (Cat. #01886). The responsible firm on the la
Some of the product lots exhibit no growth of quality control strains of Neisseria gonorrhoeae
Z-0069-04 · View FDA record ↗ - Becton Dickinson & Co.TerminatedDec 18, 2002
Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitalex), microbiological media plates.
Microbiological media may exhibit No Growth or reduced colony size of Haemophilus species.
Z-0345-03 · View FDA record ↗ - Becton Dickinson & Co.TerminatedUnknown
BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi.
Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the identification of Neisseria contributing to a delay in time to definitive diagnosis or a delay in proper treatment
Z-1377-2021 · View FDA record ↗ - Becton Dickinson & Co.TerminatedUnknown
BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi.
Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the identification of Neisseria contributing to a delay in time to definitive diagnosis or a delay in proper treatment
Z-1378-2021 · View FDA record ↗ - Becton Dickinson & Co.TerminatedUnknown
BD BBL GC-Lect Agar; Cat. No. 297715
A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Gentamicin is an inhibitory agent of Neisseria organisms. This product is a selective plated medium to provide enhanced growth and recovery of N gonorrhoeae. Inhibited growth may cause a false negative result or a delayed result leading to incorrect or delayed treatment.
Z-2869-2018 · View FDA record ↗
Registered firms
9 firms currently registered for this product code
510(k) clearances
83 clearances for this product code
- Biomed Diagnostics IncorporatedOct 20, 2021
K210511 · InTray GC
- Biomed Diagnostics, Inc.Dec 16, 1999
K993033 · INTRAY GC
- Remel, L.P.Feb 16, 1996
K954986 · GC BASE W/ 1% GCHI
- Bioclinical Systems, Inc.Jun 30, 1995
K950196 · CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
- Bioclinical Systems, Inc.Feb 9, 1994
K933122 · MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR
- Bioclinical Systems, Inc.Feb 3, 1994
K933121 · MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR
- Hardy DiagnosticsDec 21, 1993
K934331 · THAYER MARTIN, MODIFIED PILL POCKET
- Hardy DiagnosticsDec 17, 1993
K934330 · TRANSGROW