{
  "code": "JTN",
  "deviceName": "Susceptibility Test Discs, Antimicrobial",
  "deviceClass": "II",
  "regulationNumber": "866.1620",
  "panel": "Microbiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 330,
    "last12Months": 6
  },
  "adverseEvents": {
    "total": 14,
    "last12Months": 4
  },
  "reviewDays": {
    "median": 53,
    "sampleSize": 330
  },
  "recalls": {
    "total": 47,
    "recent": [
      {
        "resNumber": "Z-2887-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Hardy Diagnostics",
        "firmAsPublished": "Hardy Diagnostics",
        "reason": "Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.",
        "initiated": "2026-06-08"
      },
      {
        "resNumber": "Z-1075-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Oxoid Limited",
        "firmAsPublished": "Oxoid Limited",
        "reason": "Mislabeling;  Levofloxacin Antimicrobial susceptibility disc packaging may  contain Norfloxacin Antimicrobial  Susceptibility discs.",
        "initiated": "2024-12-23"
      },
      {
        "resNumber": "Z-0621-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Becton, Dickinson and Company",
        "firmAsPublished": "Becton Dickinson & Co.",
        "reason": "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 result in falsely resistant result for ampicillin susceptibility",
        "initiated": "2024-11-06"
      },
      {
        "resNumber": "Z-1011-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Becton, Dickinson and Company",
        "firmAsPublished": "Becton Dickinson & Co.",
        "reason": "There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.",
        "initiated": "2024-01-08"
      },
      {
        "resNumber": "Z-1012-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Becton, Dickinson and Company",
        "firmAsPublished": "Becton Dickinson & Co.",
        "reason": "There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.",
        "initiated": "2024-01-08"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261781",
      "deviceName": "Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60",
      "applicant": "Thermo Fisher Scientific (Oxoid Ltd.)",
      "company": "Thermo Fisher Scientific (Oxoid Ltd.)",
      "decisionDate": "2026-07-24",
      "dateReceived": "2026-05-29"
    },
    {
      "kNumber": "K261853",
      "deviceName": "Gepotidacin GEP 10 µg",
      "applicant": "Liofilchem, Inc.",
      "company": "Liofilchem, Inc.",
      "decisionDate": "2026-07-23",
      "dateReceived": "2026-06-03"
    },
    {
      "kNumber": "K260842",
      "deviceName": "HardyDisk AST Gepotidacin 10µg (GEP10)",
      "applicant": "Hardy Diagnostics",
      "company": "Hardy Diagnostics",
      "decisionDate": "2026-05-11",
      "dateReceived": "2026-03-16"
    },
    {
      "kNumber": "K251337",
      "deviceName": "Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10",
      "applicant": "Thermo Fisher Scientific (Oxoid Ltd.)",
      "company": "Thermo Fisher Scientific (Oxoid Ltd.)",
      "decisionDate": "2025-12-05",
      "dateReceived": "2025-04-30"
    },
    {
      "kNumber": "K253105",
      "deviceName": "HardyDisk AST Cefiderocol 30µg (FDC30)",
      "applicant": "Hardy Diagnostics",
      "company": "Hardy Diagnostics",
      "decisionDate": "2025-11-20",
      "dateReceived": "2025-09-24"
    },
    {
      "kNumber": "K251879",
      "deviceName": "Sulopenem SPM 2 µg",
      "applicant": "Liofilchem",
      "company": "Liofilchem, Inc.",
      "decisionDate": "2025-08-12",
      "dateReceived": "2025-06-18"
    },
    {
      "kNumber": "K250956",
      "deviceName": "HardyDisk AST Gepotidacin 10µg (GEP10)",
      "applicant": "Hardy Diagnostics",
      "company": "Hardy Diagnostics",
      "decisionDate": "2025-06-26",
      "dateReceived": "2025-03-31"
    },
    {
      "kNumber": "K250885",
      "deviceName": "Ceftobiprole BPR 5 µg Disc",
      "applicant": "Liofilchem, Inc.",
      "company": "Liofilchem, Inc.",
      "decisionDate": "2025-06-23",
      "dateReceived": "2025-03-25"
    },
    {
      "kNumber": "K250789",
      "deviceName": "Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50",
      "applicant": "Thermo Fisher Scientific (Oxoid Ltd.)",
      "company": "Thermo Fisher Scientific (Oxoid Ltd.)",
      "decisionDate": "2025-06-12",
      "dateReceived": "2025-03-14"
    },
    {
      "kNumber": "K250454",
      "deviceName": "HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)",
      "applicant": "Hardy Diagnostics",
      "company": "Hardy Diagnostics",
      "decisionDate": "2025-05-15",
      "dateReceived": "2025-02-18"
    }
  ],
  "topApplicants": [
    {
      "name": "Hardy Diagnostics",
      "count": 83
    },
    {
      "name": "Bd Becton Dickinson Vacutainer Systems Preanalytic",
      "count": 43
    },
    {
      "name": "Difco Laboratories, Inc.",
      "count": 41
    },
    {
      "name": "Oxoid , Ltd.",
      "count": 31
    },
    {
      "name": "Investigacion Farmaceutica S.A. DE C.V.",
      "count": 19
    }
  ],
  "topCompanies": [
    {
      "name": "Hardy Diagnostics",
      "count": 83,
      "spellings": 1
    },
    {
      "name": "Bd Becton Dickinson Vacutainer Systems Preanalytic",
      "count": 43,
      "spellings": 1
    },
    {
      "name": "Difco Laboratories, Inc.",
      "count": 41,
      "spellings": 1
    },
    {
      "name": "Oxoid Limited",
      "count": 31,
      "spellings": 1
    },
    {
      "name": "Investigacion Farmaceutica S.A. DE C.V.",
      "count": 19,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "JTN (Susceptibility Test Discs, Antimicrobial) has one finding. 1 recall opened in the last 12 months and not yet terminated (Z-2887-2026).",
    "severity": 70,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated",
        "recordIds": [
          "Z-2887-2026"
        ],
        "severity": 70
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AJTN"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJTN"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJTN"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJTN"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJTN"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJTN"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJTN"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.727Z"
}