{
  "companyId": "48849",
  "slug": "beckman-coulter-inc-48849",
  "name": "Beckman Coulter, Inc.",
  "clearances": {
    "total": 277,
    "last12Months": 9,
    "first": "1993-10-12",
    "latest": "2026-03-24"
  },
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  "productCodeCount": 97,
  "recalls": {
    "total": 640,
    "openLast12Months": 21,
    "recent": [
      {
        "resNumber": "Z-2888-2026",
        "productCode": "LON",
        "status": "Open, Classified",
        "recallClass": null,
        "initiated": "2026-06-26",
        "reason": "Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications.\""
      },
      {
        "resNumber": "Z-2889-2026",
        "productCode": "LON",
        "status": "Open, Classified",
        "recallClass": null,
        "initiated": "2026-06-26",
        "reason": "Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications.\""
      },
      {
        "resNumber": "Z-1922-2026",
        "productCode": "KLI",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-03-16",
        "reason": "Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications."
      },
      {
        "resNumber": "Z-1235-2026",
        "productCode": "PER",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-12-23",
        "reason": "Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management."
      },
      {
        "resNumber": "Z-1025-2026",
        "productCode": "JJE",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-11-26",
        "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."
      }
    ]
  },
  "registration": {
    "sites": 10,
    "countries": [
      "US"
    ]
  },
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    {
      "code": "GKZ",
      "deviceName": "Counter, Differential Cell",
      "clearances": 28,
      "latest": "2024-07-05",
      "medianReviewDays": 68
    },
    {
      "code": "LTT",
      "deviceName": "Panels, Test, Susceptibility, Antimicrobial",
      "clearances": 12,
      "latest": "2025-08-20",
      "medianReviewDays": 91
    },
    {
      "code": "JPK",
      "deviceName": "Mixture, Hematology Quality Control",
      "clearances": 10,
      "latest": "2010-12-21",
      "medianReviewDays": 34
    },
    {
      "code": "MMI",
      "deviceName": "Immunoassay Method, Troponin Subunit",
      "clearances": 10,
      "latest": "2025-08-01",
      "medianReviewDays": 270
    },
    {
      "code": "JJX",
      "deviceName": "Single (Specified) Analyte Controls (Assayed And Unassayed)",
      "clearances": 9,
      "latest": "2011-11-04",
      "medianReviewDays": 28
    },
    {
      "code": "JIT",
      "deviceName": "Calibrator, Secondary",
      "clearances": 8,
      "latest": "2015-02-26",
      "medianReviewDays": 39
    },
    {
      "code": "LGD",
      "deviceName": "Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii",
      "clearances": 7,
      "latest": "2025-03-28",
      "medianReviewDays": 53
    },
    {
      "code": "JIS",
      "deviceName": "Calibrator, Primary",
      "clearances": 6,
      "latest": "2001-05-10",
      "medianReviewDays": 55
    },
    {
      "code": "JJY",
      "deviceName": "Multi-Analyte Controls, All Kinds (Assayed)",
      "clearances": 6,
      "latest": "2002-03-01",
      "medianReviewDays": 15
    },
    {
      "code": "CGN",
      "deviceName": "Acid, Folic, Radioimmunoassay",
      "clearances": 5,
      "latest": "2023-08-23",
      "medianReviewDays": 119
    },
    {
      "code": "LCP",
      "deviceName": "Assay, Glycosylated Hemoglobin",
      "clearances": 5,
      "latest": "2014-07-14",
      "medianReviewDays": 113
    },
    {
      "code": "MSW",
      "deviceName": "System, Test, Thyroglobulin",
      "clearances": 5,
      "latest": "2024-06-28",
      "medianReviewDays": 31
    },
    {
      "code": "OYE",
      "deviceName": "Flow Cytometric Reagents And Accessories.",
      "clearances": 5,
      "latest": "2023-11-22",
      "medianReviewDays": 249
    },
    {
      "code": "CDD",
      "deviceName": "Radioassay, Vitamin B12",
      "clearances": 4,
      "latest": "2022-12-23",
      "medianReviewDays": 84
    },
    {
      "code": "CDZ",
      "deviceName": "Radioimmunoassay, Testosterones And Dihydrotestosterone",
      "clearances": 4,
      "latest": "2024-02-08",
      "medianReviewDays": 65
    },
    {
      "code": "CFN",
      "deviceName": "Method, Nephelometric, Immunoglobulins (G, A, M)",
      "clearances": 4,
      "latest": "2017-01-09",
      "medianReviewDays": 105
    },
    {
      "code": "CGX",
      "deviceName": "Alkaline Picrate, Colorimetry, Creatinine",
      "clearances": 4,
      "latest": "2007-06-01",
      "medianReviewDays": 25
    },
    {
      "code": "DCK",
      "deviceName": "C-Reactive Protein, Antigen, Antiserum, And Control",
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      "latest": "2001-05-29",
      "medianReviewDays": 60
    },
    {
      "code": "DDR",
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      "latest": "2023-09-18",
      "medianReviewDays": 71
    },
    {
      "code": "JHX",
      "deviceName": "Fluorometric Method, Cpk Or Isoenzymes",
      "clearances": 4,
      "latest": "2024-02-16",
      "medianReviewDays": 17
    },
    {
      "code": "JLW",
      "deviceName": "Radioimmunoassay, Thyroid-Stimulating Hormone",
      "clearances": 4,
      "latest": "2022-11-10",
      "medianReviewDays": 68
    },
    {
      "code": "JWY",
      "deviceName": "Manual Antimicrobial Susceptibility Test Systems",
      "clearances": 4,
      "latest": "2021-05-18",
      "medianReviewDays": 77
    },
    {
      "code": "CGR",
      "deviceName": "Radioimmunoassay, Cortisol",
      "clearances": 3,
      "latest": "2025-03-05",
      "medianReviewDays": 132
    },
    {
      "code": "DHX",
      "deviceName": "System, Test, Carcinoembryonic Antigen",
      "clearances": 3,
      "latest": "2023-09-22",
      "medianReviewDays": 111
    },
    {
      "code": "DKB",
      "deviceName": "Calibrators, Drug Mixture",
      "clearances": 3,
      "latest": "2000-01-11",
      "medianReviewDays": 51
    }
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  "productCodesTotal": "97",
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      "kNumber": "K252169",
      "deviceName": "Access BNP II",
      "productCode": "NBC",
      "decisionDate": "2026-03-24",
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      "kNumber": "K254059",
      "deviceName": "Access anti-HBc IgM",
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    {
      "kNumber": "K253687",
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      "deviceName": "MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)",
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      "decisionDate": "2025-08-15",
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      "deviceName": "Access hsTnI",
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        "dataset": "device/registrationlisting",
        "method": "normalised"
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        "method": "normalised"
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        "name": "Beckman Coulter Inc.",
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    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Beckman%20Coulter%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Beckman%20Coulter%2C%20Inc.%22"
  },
  "provenance": [
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  "retrievedAt": "2026-08-11T14:48:53.026Z"
}