{
  "code": "JJE",
  "deviceName": "Analyzer, Chemistry (Photometric, Discrete), For Clinical Use",
  "deviceClass": "I",
  "regulationNumber": "862.2160",
  "panel": "Clinical Chemistry",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 208,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 12531,
    "last12Months": 2968
  },
  "reviewDays": {
    "median": 53,
    "sampleSize": 208
  },
  "recalls": {
    "total": 559,
    "recent": [
      {
        "resNumber": "Z-1476-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Roche Diagnostics Operations, Inc.",
        "firmAsPublished": "Roche Diagnostics Operations, Inc.",
        "reason": "Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.",
        "initiated": "2026-01-20"
      },
      {
        "resNumber": "Z-1025-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Beckman Coulter, Inc.",
        "firmAsPublished": "Beckman Coulter, Inc.",
        "reason": "Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.",
        "initiated": "2025-11-26"
      },
      {
        "resNumber": "Z-1026-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Beckman Coulter, Inc.",
        "firmAsPublished": "Beckman Coulter, Inc.",
        "reason": "Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.",
        "initiated": "2025-11-26"
      },
      {
        "resNumber": "Z-0961-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Abbott Laboratories, Inc.",
        "firmAsPublished": "Abbott Laboratories",
        "reason": "Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.",
        "initiated": "2025-11-13"
      },
      {
        "resNumber": "Z-0889-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Beckman Coulter, Inc.",
        "firmAsPublished": "Beckman Coulter, Inc.",
        "reason": "It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.",
        "initiated": "2025-11-07"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K183375",
      "deviceName": "Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode",
      "applicant": "Horiba, Ltd.",
      "company": "Horiba, Ltd.",
      "decisionDate": "2019-02-12",
      "dateReceived": "2018-12-06"
    },
    {
      "kNumber": "K133519",
      "deviceName": "CAROLINA LIQUID CHEMISTRIES CLC 6410  CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR",
      "applicant": "Carolina Liquid Chemistries Corp.",
      "company": "Carolina Liquid Chemistries",
      "decisionDate": "2014-05-16",
      "dateReceived": "2013-11-15"
    },
    {
      "kNumber": "K130915",
      "deviceName": "XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK",
      "applicant": "Jas Diagnostics, Inc.",
      "company": "JAS Diagnostics Inc.",
      "decisionDate": "2014-05-15",
      "dateReceived": "2013-04-02"
    },
    {
      "kNumber": "K131554",
      "deviceName": "RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT",
      "applicant": "Randox Laboratories, Ltd.",
      "company": "Randox Laboratories, Limited",
      "decisionDate": "2014-01-09",
      "dateReceived": "2013-05-30"
    },
    {
      "kNumber": "K130276",
      "deviceName": "DIMENSION EXL WITH LM SYSTEM",
      "applicant": "Siemens Healthcare Diagnostics, Inc.",
      "company": "Siemens Healthcare Diagnostics, Inc.",
      "decisionDate": "2013-03-22",
      "dateReceived": "2013-02-05"
    },
    {
      "kNumber": "K113253",
      "deviceName": "ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT",
      "applicant": "Alfa Wassermann Diagnostic Technologies, Inc.",
      "company": "Alfa Wassermann Diagnostic Technologies, Inc.",
      "decisionDate": "2012-05-17",
      "dateReceived": "2011-11-02"
    },
    {
      "kNumber": "K112999",
      "deviceName": "DIMENSION CLINICAL CHEMISTRY SYSTEM",
      "applicant": "Siemens Healthcare Diagnostics",
      "company": "Siemens Healthcare Diagnostics, Inc.",
      "decisionDate": "2011-11-22",
      "dateReceived": "2011-10-07"
    },
    {
      "kNumber": "K110035",
      "deviceName": "INDIKO",
      "applicant": "Thermofisher Scientific OY",
      "company": "ThermoFisher Scientific Co., LLC",
      "decisionDate": "2011-06-28",
      "dateReceived": "2011-01-05"
    },
    {
      "kNumber": "K073370",
      "deviceName": "TC MATRIX CLINICAL CHEMISTRY ANALYZER",
      "applicant": "Teco Diagnostics",
      "company": "Teco Diagnostics",
      "decisionDate": "2008-05-08",
      "dateReceived": "2007-11-30"
    },
    {
      "kNumber": "K063144",
      "deviceName": "VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM",
      "applicant": "Ortho-Clinical Diagnostics, Inc.",
      "company": "Ortho-Clinical Diagnostics, Inc.",
      "decisionDate": "2006-11-13",
      "dateReceived": "2006-10-16"
    }
  ],
  "topApplicants": [
    {
      "name": "Eastman Kodak Company",
      "count": 18
    },
    {
      "name": "Boehringer Mannheim Corp.",
      "count": 16
    },
    {
      "name": "Abbott Laboratories",
      "count": 13
    },
    {
      "name": "Beckman Instruments, Inc.",
      "count": 9
    },
    {
      "name": "Ciba Corning Diagnostics Corp.",
      "count": 7
    }
  ],
  "topCompanies": [
    {
      "name": "Eastman Kodak Company",
      "count": 18,
      "spellings": 1
    },
    {
      "name": "Boehringer Mannheim Corp.",
      "count": 16,
      "spellings": 1
    },
    {
      "name": "Abbott Laboratories, Inc.",
      "count": 13,
      "spellings": 1
    },
    {
      "name": "Beckman Instruments, Inc.",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Ciba Corning Diagnostics Corp.",
      "count": 7,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 335,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 308,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 348,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 298,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 304,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 297,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 238,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 304,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 279,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 299,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 359,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 328,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 335,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 367,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 281,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 356,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 391,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 344,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 397,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 359,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 405,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 316,
        "expectedLow": 294.7544716216217,
        "expectedHigh": 385.0077514128248,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 289,
        "expectedLow": 257.32652528525153,
        "expectedHigh": 323.8156748654638,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 350,
        "expectedLow": 289.3602184190375,
        "expectedHigh": 359.28443387593234,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 386,
        "expectedLow": 303.7358367227678,
        "expectedHigh": 382.85418916690395,
        "isSufficient": true
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      {
        "month": "2025-05-01",
        "observed": 353,
        "expectedLow": 288.1563488613423,
        "expectedHigh": 379.86043775780433,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 351,
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        "expectedHigh": 403.3095091782656,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 392,
        "expectedLow": 481.82410090117435,
        "expectedHigh": 623.8203571145748,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 324,
        "expectedLow": 302.940722448751,
        "expectedHigh": 460.8469848740688,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 399,
        "expectedLow": 289.6887956010618,
        "expectedHigh": 476.56842299194506,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 377,
        "expectedLow": 293.3211981646796,
        "expectedHigh": 478.1594321482286,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 352,
        "expectedLow": 260.57543791926156,
        "expectedHigh": 429.66091741200967,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 436,
        "expectedLow": 291.2285634672419,
        "expectedHigh": 479.24248619630464,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 324,
        "expectedLow": 353.32286712024285,
        "expectedHigh": 569.0115244083887,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 404,
        "expectedLow": 241.56623006408574,
        "expectedHigh": 469.55684787683697,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 452,
        "expectedLow": 280.7298445586759,
        "expectedHigh": 531.7220268517849,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use) has one finding. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1476-2026, Z-1025-2026, Z-1026-2026, Z-0961-2026, Z-0889-2026).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1476-2026",
          "Z-1025-2026",
          "Z-1026-2026",
          "Z-0961-2026",
          "Z-0889-2026"
        ],
        "severity": 75
      }
    ],
    "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%3AJJE"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJJE"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJJE"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJJE"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJJE"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJJE"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJJE"
    }
  ],
  "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": "2026-08-11T13:51:45.719Z"
}