FDA Device Intelligence
HomeDevice types › JTN

Susceptibility Test Discs, Antimicrobial

FDA product code JTN · Class 2 · Microbiology

361
Registered devices
35
Adverse events
47
Recalls
330
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-06-08Hardy DiagnosticsDue to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lea
2024-12-23Oxoid LimitedMislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs.
2024-11-06Becton Dickinson & Co.BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may
2024-01-08Becton Dickinson & Co.There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis
2024-01-08Becton Dickinson & Co.There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis
2024-01-08Becton Dickinson & Co.There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis
2024-01-08Becton Dickinson & Co.There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis
2024-01-08Becton Dickinson & Co.There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis
2024-01-08Becton Dickinson & Co.There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis
2024-01-08Becton Dickinson & Co.There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product dis

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.