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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

Recent recalls

DateFirmReason
2026-06-03Remel, IncReduced or no recovery of some strains of Neisseria gonorrhoeae.
2022-11-21Becton 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
2021-03-17Becton 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
2021-03-17Becton 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
2018-06-21Becton 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
2013-02-08Becton Dickinson & Co.Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.
2003-10-10Becton Dickinson & CoMicrobiological media may exhibit reduced colony size of bacteria, Haemophilus species.
2003-10-02Remel, IncSome of the product lots exhibit no growth of quality control strains of Neisseria gonorrhoeae
2002-11-18Becton Dickinson & Co.Microbiological media may exhibit No Growth or reduced colony size of Haemophilus species.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.