{
  "companyId": "53907",
  "slug": "hardy-diagnostics-53907",
  "name": "Hardy Diagnostics",
  "clearances": {
    "total": 109,
    "last12Months": 2,
    "first": "1993-04-23",
    "latest": "2026-05-11"
  },
  "medianReviewDays": 57,
  "productCodeCount": 8,
  "recalls": {
    "total": 20,
    "openLast12Months": 1,
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      {
        "resNumber": "Z-2887-2026",
        "productCode": "JTN",
        "status": "Open, Classified",
        "recallClass": null,
        "initiated": "2026-06-08",
        "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."
      },
      {
        "resNumber": "Z-2041-2025",
        "productCode": "JSO",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-05-06",
        "reason": "Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae."
      },
      {
        "resNumber": "Z-1835-2021",
        "productCode": "KPA",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2021-04-16",
        "reason": "Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit."
      },
      {
        "resNumber": "Z-0919-2021",
        "productCode": "JSO",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2020-12-21",
        "reason": "Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited."
      },
      {
        "resNumber": "Z-0655-2021",
        "productCode": "JSM",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2020-10-23",
        "reason": "There is a potential for contamination within Viral  Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing."
      }
    ]
  },
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    "sites": 2,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "JTN",
      "deviceName": "Susceptibility Test Discs, Antimicrobial",
      "clearances": 83,
      "latest": "2026-05-11",
      "medianReviewDays": 53
    },
    {
      "code": "JTO",
      "deviceName": "Discs, Strips And Reagents, Microorganism Differentiation",
      "clearances": 10,
      "latest": "1996-06-17",
      "medianReviewDays": 71
    },
    {
      "code": "JSO",
      "deviceName": "Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar",
      "clearances": 5,
      "latest": "2019-04-29",
      "medianReviewDays": 182
    },
    {
      "code": "JSM",
      "deviceName": "Culture Media, Non-Propagating Transport",
      "clearances": 3,
      "latest": "2024-08-02",
      "medianReviewDays": 236
    },
    {
      "code": "JTY",
      "deviceName": "Culture Media, For Isolation Of Pathogenic Neisseria",
      "clearances": 3,
      "latest": "1993-12-21",
      "medianReviewDays": 109
    },
    {
      "code": "PQZ",
      "deviceName": "Gbs Culture Media, Selective And Differential",
      "clearances": 3,
      "latest": "2018-03-22",
      "medianReviewDays": 89
    },
    {
      "code": "JXC",
      "deviceName": "Kit, Screening, Yeast",
      "clearances": 1,
      "latest": "1996-08-02",
      "medianReviewDays": 204
    },
    {
      "code": "LKS",
      "deviceName": "Device, Parasite Concentration",
      "clearances": 1,
      "latest": "1994-05-17",
      "medianReviewDays": 71
    }
  ],
  "productCodesShown": 8,
  "productCodesTotal": "8",
  "recentClearances": [
    {
      "kNumber": "K260842",
      "deviceName": "HardyDisk AST Gepotidacin 10µg (GEP10)",
      "productCode": "JTN",
      "decisionDate": "2026-05-11",
      "reviewDays": 56
    },
    {
      "kNumber": "K253105",
      "deviceName": "HardyDisk AST Cefiderocol 30µg (FDC30)",
      "productCode": "JTN",
      "decisionDate": "2025-11-20",
      "reviewDays": 57
    },
    {
      "kNumber": "K250956",
      "deviceName": "HardyDisk AST Gepotidacin 10µg (GEP10)",
      "productCode": "JTN",
      "decisionDate": "2025-06-26",
      "reviewDays": 87
    },
    {
      "kNumber": "K250454",
      "deviceName": "HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)",
      "productCode": "JTN",
      "decisionDate": "2025-05-15",
      "reviewDays": 86
    },
    {
      "kNumber": "K233534",
      "deviceName": "Viral Transport Medium",
      "productCode": "JSM",
      "decisionDate": "2024-08-02",
      "reviewDays": 273
    },
    {
      "kNumber": "K241060",
      "deviceName": "HardyDisk AST Cefiderocol 30µg (FDC30)",
      "productCode": "JTN",
      "decisionDate": "2024-07-18",
      "reviewDays": 91
    },
    {
      "kNumber": "K231568",
      "deviceName": "HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)",
      "productCode": "JTN",
      "decisionDate": "2023-07-06",
      "reviewDays": 36
    },
    {
      "kNumber": "K230827",
      "deviceName": "HardyDisk AST Rezafungin 5µg (RZF5)",
      "productCode": "JTN",
      "decisionDate": "2023-06-01",
      "reviewDays": 66
    },
    {
      "kNumber": "K193504",
      "deviceName": "HardyDisk AST Cefiderocol 30ug (FDC30)",
      "productCode": "JTN",
      "decisionDate": "2020-01-23",
      "reviewDays": 36
    },
    {
      "kNumber": "K192326",
      "deviceName": "HardyDisk AST Lefamulin 20µg (LMU20)",
      "productCode": "JTN",
      "decisionDate": "2019-09-19",
      "reviewDays": 23
    }
  ],
  "nameVariants": {
    "total": "5",
    "shown": [
      {
        "name": "HARDY DIAGNOSTICS",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Hardy Diagnostics",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Hardy Diagnostics",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Hardy Diagnostics",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Hardy Diagnostics",
        "dataset": "device/enforcement",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Hardy%20Diagnostics%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Hardy%20Diagnostics%22"
  },
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
      "ingestRun": 74
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10
    }
  ],
  "retrievedAt": "2026-08-11T14:48:53.041Z"
}