{
  "code": "JSI",
  "deviceName": "Culture Media, Selective And Differential",
  "deviceClass": "I",
  "regulationNumber": "866.2360",
  "panel": "Microbiology",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 285,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 97,
    "last12Months": 38
  },
  "reviewDays": {
    "median": 23,
    "sampleSize": 285
  },
  "recalls": {
    "total": 24,
    "recent": [
      {
        "resNumber": "Z-2224-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Remel, Inc.",
        "firmAsPublished": "Remel, Inc",
        "reason": "The products may contain surface and subsurface contamination of Listeria monocytogenes.",
        "initiated": "2025-07-11"
      },
      {
        "resNumber": "Z-2225-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Remel, Inc.",
        "firmAsPublished": "Remel, Inc",
        "reason": "The products may contain surface and subsurface contamination of Listeria monocytogenes.",
        "initiated": "2025-07-11"
      },
      {
        "resNumber": "Z-2226-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Remel, Inc.",
        "firmAsPublished": "Remel, Inc",
        "reason": "The products may contain surface and subsurface contamination of Listeria monocytogenes.",
        "initiated": "2025-07-11"
      },
      {
        "resNumber": "Z-1829-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
        "firmAsPublished": "Mckesson Medical-Surgical Inc. Corporate Office",
        "reason": "transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.",
        "initiated": "2025-04-24"
      },
      {
        "resNumber": "Z-1200-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Remel, Inc.",
        "firmAsPublished": "Remel, Inc",
        "reason": "Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.",
        "initiated": "2025-02-13"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K070691",
      "deviceName": "BBL CHROMAGAR 0157",
      "applicant": "Becton, Dickinson & CO",
      "company": "Becton, Dickinson and Company",
      "decisionDate": "2007-11-20",
      "dateReceived": "2007-03-13"
    },
    {
      "kNumber": "K974428",
      "deviceName": "DIPSTREAK",
      "applicant": "Novamed , Ltd.",
      "company": "NOVAMED CO., LTD.",
      "decisionDate": "1998-07-30",
      "dateReceived": "1997-11-24"
    },
    {
      "kNumber": "K891593",
      "deviceName": "LISTERIA SELECTIVE ENRICHMENT MEDIUM",
      "applicant": "Oxoid U.S.A., Inc.",
      "company": "Oxoid U.S.A., Inc.",
      "decisionDate": "1989-06-09",
      "dateReceived": "1989-03-20"
    },
    {
      "kNumber": "K890199",
      "deviceName": "DENTOCULT SM-STRIP MUTANS",
      "applicant": "Orion Corp.",
      "company": "Orion Corp.",
      "decisionDate": "1989-03-02",
      "dateReceived": "1989-01-18"
    },
    {
      "kNumber": "K882182",
      "deviceName": "SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326",
      "applicant": "Lakewood Biochemical Co., Inc.",
      "company": "Lakewood Biochemical Co., Inc.",
      "decisionDate": "1988-06-06",
      "dateReceived": "1988-05-24"
    },
    {
      "kNumber": "K881577",
      "deviceName": "MODIFIED SELECTIVE STREPTOCOCCUS AGAR",
      "applicant": "Acumedia Manufacturers, Inc.",
      "company": "Acumedia Manufacturers, Inc.",
      "decisionDate": "1988-04-18",
      "dateReceived": "1988-04-11"
    },
    {
      "kNumber": "K881576",
      "deviceName": "SELENITE BROTH",
      "applicant": "Acumedia Manufacturers, Inc.",
      "company": "Acumedia Manufacturers, Inc.",
      "decisionDate": "1988-04-18",
      "dateReceived": "1988-04-11"
    },
    {
      "kNumber": "K881575",
      "deviceName": "SELECTIVE STREPTOCOCCUS AGAR",
      "applicant": "Acumedia Manufacturers, Inc.",
      "company": "Acumedia Manufacturers, Inc.",
      "decisionDate": "1988-04-18",
      "dateReceived": "1988-04-11"
    },
    {
      "kNumber": "K881572",
      "deviceName": "XL AGAR BASE",
      "applicant": "Acumedia Manufacturers, Inc.",
      "company": "Acumedia Manufacturers, Inc.",
      "decisionDate": "1988-04-18",
      "dateReceived": "1988-04-11"
    },
    {
      "kNumber": "K881556",
      "deviceName": "TRICHOMONAS BROTH",
      "applicant": "Acumedia Manufacturers, Inc.",
      "company": "Acumedia Manufacturers, Inc.",
      "decisionDate": "1988-04-18",
      "dateReceived": "1988-04-08"
    }
  ],
  "topApplicants": [
    {
      "name": "Acumedia Manufacturers, Inc.",
      "count": 40
    },
    {
      "name": "Otisville Biotech, Inc.",
      "count": 20
    },
    {
      "name": "Hardy Media",
      "count": 17
    },
    {
      "name": "Isle Media and Sterile Products, Inc.",
      "count": 15
    },
    {
      "name": "Lakewood Biochemical Co., Inc.",
      "count": 14
    }
  ],
  "topCompanies": [
    {
      "name": "Acumedia Manufacturers, Inc.",
      "count": 40,
      "spellings": 1
    },
    {
      "name": "Otisville Biotech, Inc.",
      "count": 20,
      "spellings": 1
    },
    {
      "name": "Hardy Media Inc Dba Hardy Diag",
      "count": 17,
      "spellings": 1
    },
    {
      "name": "Isle Media and Sterile Products, Inc.",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Lakewood Biochemical Co., Inc.",
      "count": 14,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 30,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "JSI (Culture Media, Selective And Differential): nothing changed in the six FDA sources we watch.",
    "severity": 1,
    "factors": [],
    "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%3AJSI"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJSI"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJSI"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJSI"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJSI"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJSI"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJSI"
    }
  ],
  "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": "2026-08-11T13:51:45.726Z"
}