{
  "code": "CHL",
  "deviceName": "Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph",
  "deviceClass": "II",
  "regulationNumber": "862.1120",
  "panel": "Clinical Chemistry",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 188,
    "last12Months": 1
  },
  "adverseEvents": {
    "total": 586,
    "last12Months": 103
  },
  "reviewDays": {
    "median": 66,
    "sampleSize": 188
  },
  "recalls": {
    "total": 182,
    "recent": [
      {
        "resNumber": "Z-2821-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Instrumentation Laboratory",
        "firmAsPublished": "Instrumentation Laboratory",
        "reason": "BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the \"price check\" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.",
        "initiated": "2026-05-08"
      },
      {
        "resNumber": "Z-2822-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Instrumentation Laboratory",
        "firmAsPublished": "Instrumentation Laboratory",
        "reason": "BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the \"price check\" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.",
        "initiated": "2026-05-08"
      },
      {
        "resNumber": "Z-2823-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Instrumentation Laboratory",
        "firmAsPublished": "Instrumentation Laboratory",
        "reason": "BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the \"price check\" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.",
        "initiated": "2026-05-08"
      },
      {
        "resNumber": "Z-2824-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Instrumentation Laboratory",
        "firmAsPublished": "Instrumentation Laboratory",
        "reason": "BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the \"price check\" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.",
        "initiated": "2026-05-08"
      },
      {
        "resNumber": "Z-2825-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Instrumentation Laboratory",
        "firmAsPublished": "Instrumentation Laboratory",
        "reason": "BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the \"price check\" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.",
        "initiated": "2026-05-08"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K252207",
      "deviceName": "ABL90 FLEX PLUS System, safeCLINITUBES",
      "applicant": "Radiometer Medicals Aps",
      "company": "Radiometer Medicals Aps",
      "decisionDate": "2026-04-10",
      "dateReceived": "2025-07-14"
    },
    {
      "kNumber": "K244014",
      "deviceName": "i-STAT CG4+ cartridge with the i-STAT 1 System",
      "applicant": "Abbott Point of Care, Inc.",
      "company": "Abbott Point Of Care Inc.",
      "decisionDate": "2025-05-02",
      "dateReceived": "2024-12-26"
    },
    {
      "kNumber": "K240998",
      "deviceName": "ABL90 FLEX PLUS System",
      "applicant": "Radiometer Medicals Aps",
      "company": "Radiometer Medicals Aps",
      "decisionDate": "2024-12-13",
      "dateReceived": "2024-04-11"
    },
    {
      "kNumber": "K230285",
      "deviceName": "i-STAT CG8+ cartridge with the i-STAT 1 System",
      "applicant": "Abbott Point of Care, Inc.",
      "company": "Abbott Point Of Care Inc.",
      "decisionDate": "2023-10-27",
      "dateReceived": "2023-02-02"
    },
    {
      "kNumber": "K221900",
      "deviceName": "Stat Profile Prime Plus Analyzer System",
      "applicant": "Nova Biomedical Corporation",
      "company": "Nova Biomedical Corporation",
      "decisionDate": "2023-09-29",
      "dateReceived": "2022-06-30"
    },
    {
      "kNumber": "K223857",
      "deviceName": "i-STAT G3+ cartridge with the i-STAT 1 System",
      "applicant": "Abbott Point of Care, Inc.",
      "company": "Abbott Point Of Care Inc.",
      "decisionDate": "2023-09-15",
      "dateReceived": "2022-12-23"
    },
    {
      "kNumber": "K223608",
      "deviceName": "GEM Premier 7000 with IQM3",
      "applicant": "Instrumentation Laboratory Company",
      "company": "Instrumentation Laboratory",
      "decisionDate": "2023-08-10",
      "dateReceived": "2022-12-02"
    },
    {
      "kNumber": "K211559",
      "deviceName": "EasyStat 300",
      "applicant": "Medica Corporation",
      "company": "Medica Corporation",
      "decisionDate": "2023-01-27",
      "dateReceived": "2021-05-20"
    },
    {
      "kNumber": "K203790",
      "deviceName": "GEM Premier 5000",
      "applicant": "Instrumentation Laboratory CO",
      "company": "Instrumentation Laboratory",
      "decisionDate": "2021-08-20",
      "dateReceived": "2020-12-28"
    },
    {
      "kNumber": "K200986",
      "deviceName": "OPTI® B-Lac Cassette",
      "applicant": "Opti Medical Systems, Inc.",
      "company": "OPTI Medical Systems, Inc",
      "decisionDate": "2021-08-02",
      "dateReceived": "2020-04-15"
    }
  ],
  "topApplicants": [
    {
      "name": "Nova Biomedical Corp.",
      "count": 20
    },
    {
      "name": "Fisher Scientific Co., LLC",
      "count": 15
    },
    {
      "name": "Instrumentation Laboratory CO",
      "count": 15
    },
    {
      "name": "Radiometer America, Inc.",
      "count": 15
    },
    {
      "name": "Radiometer Medical Aps",
      "count": 13
    }
  ],
  "topCompanies": [
    {
      "name": "Nova Biomedical Corporation",
      "count": 28,
      "spellings": 2
    },
    {
      "name": "Instrumentation Laboratory",
      "count": 16,
      "spellings": 2
    },
    {
      "name": "Fisher Scientific Co",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Radiometer America Inc",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Radiometer Medical ApS",
      "count": 13,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 23,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 23,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 17,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 17,
        "expectedLow": 6.261694959026047,
        "expectedHigh": 24.19125164056598,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 16,
        "expectedLow": 6.849209145435085,
        "expectedHigh": 20.653136331903205,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 27,
        "expectedLow": 9.154938103864687,
        "expectedHigh": 23.328811053983877,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 20,
        "expectedLow": 10.477453111083765,
        "expectedHigh": 29.913261144497987,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 24,
        "expectedLow": 10.248603542306757,
        "expectedHigh": 27.325319579163214,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 17,
        "expectedLow": 11.126189382234838,
        "expectedHigh": 30.979612162578437,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 26,
        "expectedLow": 16.449086441889058,
        "expectedHigh": 45.95553523945888,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 11,
        "expectedLow": 11.894324570335954,
        "expectedHigh": 33.00002360347532,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 14,
        "expectedLow": 7.322588085472723,
        "expectedHigh": 32.93843666020781,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 13,
        "expectedLow": 5.147711687753032,
        "expectedHigh": 30.936517715736496,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 8,
        "expectedLow": 2.5518874294782843,
        "expectedHigh": 27.163479200522932,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 9,
        "expectedLow": 0,
        "expectedHigh": 29.206540526898163,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 12,
        "expectedLow": 0,
        "expectedHigh": 33.36312965439064,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 10,
        "expectedLow": 0,
        "expectedHigh": 28.269654383176874,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 31,
        "expectedLow": 0,
        "expectedHigh": 30.994642832127877,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph) has two findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Z-2821-2026, Z-2822-2026, Z-2823-2026, Z-2824-2026, Z-2825-2026). Adverse events reported in 2026-03 ran high — 31 reports against an expected 0 to 31 (CHL:MAUDE:2026-03).",
    "severity": 70,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated",
        "recordIds": [
          "Z-2821-2026",
          "Z-2822-2026",
          "Z-2823-2026",
          "Z-2824-2026",
          "Z-2825-2026"
        ],
        "severity": 70
      },
      {
        "kind": "spike",
        "detail": "adverse events reported in 2026-03 ran high — 31 reports against an expected 0 to 31",
        "recordIds": [
          "CHL:MAUDE:2026-03"
        ],
        "severity": 60
      }
    ],
    "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%3ACHL"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACHL"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACHL"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ACHL"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ACHL"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ACHL"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ACHL"
    }
  ],
  "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": "2026-08-11T13:51:45.672Z"
}