Home › Device types › JTY
Culture Media, For Isolation Of Pathogenic Neisseria
FDA product code JTY · Class 2 · Microbiology
42
Registered devices
82
Adverse events
9
Recalls
83
510(k) clearances
Devices with this code
NA — REMEL, INC.NA — REMEL, INC.BD BBL™ Martin-Lewis Agar — BECTON, DICKINSON AND COMPANYNA — REMEL, INC.NA — HARDY DIAGNOSTICSMODIFIED THAYER MARTIN — HealthlinkBD BBL™ Modified Thayer-Martin (MTM II) Agar — BECTON, DICKINSON AND COMPANYNA — REMEL, INC.NA — REMEL, INC.MARTIN LEWIS AGAR — HealthlinkBD BBL™ Martin-Lewis Agar — BECTON, DICKINSON AND COMPANYMARTIN LEWIS G.C. SYSTEM — HealthlinkNA — HARDY DIAGNOSTICSNA — REMEL, INC.BD BBL™ Chocolate II Agar with Bacitracin — BECTON, DICKINSON AND COMPANYNA — REMEL, INC.NA — HARDY DIAGNOSTICSNA — REMEL, INC.NA — REMEL, INC.NA — HARDY DIAGNOSTICSNA — HARDY DIAGNOSTICSInTray™ GC — BIO-MED DIAGNOSTICS, INC.NA — HARDY DIAGNOSTICSNA — REMEL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-03 | Remel, Inc | Reduced or no recovery of some strains of Neisseria gonorrhoeae. |
| 2022-11-21 | Becton Dickinson & Co. | Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus gro |
| 2021-03-17 | Becton Dickinson & Co. | Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubati |
| 2021-03-17 | Becton Dickinson & Co. | Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubati |
| 2018-06-21 | Becton Dickinson & Co. | A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Gentamicin is an inhibitory agent of Neisseria organisms. This product is a selec |
| 2013-02-08 | Becton Dickinson & Co. | Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits. |
| 2003-10-10 | Becton Dickinson & Co | Microbiological media may exhibit reduced colony size of bacteria, Haemophilus species. |
| 2003-10-02 | Remel, Inc | Some of the product lots exhibit no growth of quality control strains of Neisseria gonorrhoeae |
| 2002-11-18 | Becton Dickinson & Co. | Microbiological media may exhibit No Growth or reduced colony size of Haemophilus species. |
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