{
  "companyId": "67878",
  "slug": "dade-behring-inc-67878",
  "name": "Dade Behring, Inc.",
  "clearances": {
    "total": 343,
    "last12Months": 0,
    "first": "1978-10-10",
    "latest": "2010-12-20"
  },
  "medianReviewDays": 56,
  "productCodeCount": 101,
  "recalls": {
    "total": 29,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-0581-2009",
        "productCode": "JJE",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2008-09-30",
        "reason": "Error messages, \"Wash Aspirator Failure\" and \"Wash station unable to recover\" are not generated when one or both HM wash probes are totally occluded."
      },
      {
        "resNumber": "Z-0485-2009",
        "productCode": "JFY",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2008-09-29",
        "reason": "Reagent may exhibit unflagged inaccurate patient sample results."
      },
      {
        "resNumber": "Z-0668-2009",
        "productCode": "JHX",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2008-06-23",
        "reason": "Incorrect result: Potential for false elevation of CTnI results"
      },
      {
        "resNumber": "Z-1174-2007",
        "productCode": "JJE",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2007-07-03",
        "reason": "Sample ID and Patient results could be associated with the wrong patient"
      },
      {
        "resNumber": "Z-0247-2007",
        "productCode": "LIE",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2006-09-27",
        "reason": "Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing."
      }
    ]
  },
  "registration": {
    "sites": 0,
    "countries": []
  },
  "productCodes": [
    {
      "code": "LON",
      "deviceName": "System, Test, Automated, Antimicrobial Susceptibility, Short Incubation",
      "clearances": 37,
      "latest": "2007-08-20",
      "medianReviewDays": 52
    },
    {
      "code": "JIT",
      "deviceName": "Calibrator, Secondary",
      "clearances": 29,
      "latest": "2007-12-12",
      "medianReviewDays": 28
    },
    {
      "code": "LRG",
      "deviceName": "Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems",
      "clearances": 23,
      "latest": "2007-08-20",
      "medianReviewDays": 22
    },
    {
      "code": "JIX",
      "deviceName": "Calibrator, Multi-Analyte Mixture",
      "clearances": 18,
      "latest": "2007-10-17",
      "medianReviewDays": 49
    },
    {
      "code": "JPA",
      "deviceName": "System, Multipurpose For In Vitro Coagulation Studies",
      "clearances": 12,
      "latest": "2003-01-16",
      "medianReviewDays": 79
    },
    {
      "code": "GKP",
      "deviceName": "Instrument, Coagulation, Automated",
      "clearances": 9,
      "latest": "2003-09-08",
      "medianReviewDays": 66
    },
    {
      "code": "DLJ",
      "deviceName": "Calibrators, Drug Specific",
      "clearances": 8,
      "latest": "2006-09-14",
      "medianReviewDays": 48
    },
    {
      "code": "JJY",
      "deviceName": "Multi-Analyte Controls, All Kinds (Assayed)",
      "clearances": 8,
      "latest": "2007-09-11",
      "medianReviewDays": 42
    },
    {
      "code": "JWY",
      "deviceName": "Manual Antimicrobial Susceptibility Test Systems",
      "clearances": 8,
      "latest": "2006-07-21",
      "medianReviewDays": 46
    },
    {
      "code": "MMI",
      "deviceName": "Immunoassay Method, Troponin Subunit",
      "clearances": 7,
      "latest": "2007-03-19",
      "medianReviewDays": 77
    },
    {
      "code": "CFN",
      "deviceName": "Method, Nephelometric, Immunoglobulins (G, A, M)",
      "clearances": 6,
      "latest": "2008-07-28",
      "medianReviewDays": 56
    },
    {
      "code": "DAP",
      "deviceName": "Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control",
      "clearances": 6,
      "latest": "2007-03-23",
      "medianReviewDays": 82
    },
    {
      "code": "JIS",
      "deviceName": "Calibrator, Primary",
      "clearances": 6,
      "latest": "2006-05-31",
      "medianReviewDays": 45
    },
    {
      "code": "NBC",
      "deviceName": "Test, Natriuretic Peptide",
      "clearances": 6,
      "latest": "2007-08-17",
      "medianReviewDays": 54
    },
    {
      "code": "DDG",
      "deviceName": "Transferrin, Antigen, Antiserum, Control",
      "clearances": 5,
      "latest": "2007-03-21",
      "medianReviewDays": 103
    },
    {
      "code": "DKB",
      "deviceName": "Calibrators, Drug Mixture",
      "clearances": 5,
      "latest": "2006-09-14",
      "medianReviewDays": 47
    },
    {
      "code": "DKZ",
      "deviceName": "Enzyme Immunoassay, Amphetamine",
      "clearances": 5,
      "latest": "2006-05-19",
      "medianReviewDays": 67
    },
    {
      "code": "LTT",
      "deviceName": "Panels, Test, Susceptibility, Antimicrobial",
      "clearances": 5,
      "latest": "2006-10-13",
      "medianReviewDays": 56
    },
    {
      "code": "NQD",
      "deviceName": "Cardiac C-Reactive Protein, Antigen, Antiserum, And Control",
      "clearances": 5,
      "latest": "2006-12-26",
      "medianReviewDays": 76
    },
    {
      "code": "DIO",
      "deviceName": "Enzyme Immunoassay, Cocaine And Cocaine Metabolites",
      "clearances": 4,
      "latest": "2004-02-09",
      "medianReviewDays": 63
    },
    {
      "code": "MKW",
      "deviceName": "Cyclosporine",
      "clearances": 4,
      "latest": "2006-08-21",
      "medianReviewDays": 30
    },
    {
      "code": "CFQ",
      "deviceName": "Radioimmunoassay, Immunoglobulins (G, A, M)",
      "clearances": 3,
      "latest": "1999-03-25",
      "medianReviewDays": 31
    },
    {
      "code": "CIG",
      "deviceName": "Diazo Colorimetry, Bilirubin",
      "clearances": 3,
      "latest": "2006-08-29",
      "medianReviewDays": 61
    },
    {
      "code": "CZW",
      "deviceName": "Complement C3, Antigen, Antiserum, Control",
      "clearances": 3,
      "latest": "2006-09-22",
      "medianReviewDays": 71
    },
    {
      "code": "DCN",
      "deviceName": "System, Test, C-Reactive Protein",
      "clearances": 3,
      "latest": "2006-09-06",
      "medianReviewDays": 70
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "101",
  "recentClearances": [
    {
      "kNumber": "K093848",
      "deviceName": "PT-MULTI-CALIBRATOR, MODEL OPAT07",
      "productCode": "GGN",
      "decisionDate": "2010-12-20",
      "reviewDays": 369
    },
    {
      "kNumber": "K081161",
      "deviceName": "DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST",
      "productCode": "CFN",
      "decisionDate": "2008-07-28",
      "reviewDays": 95
    },
    {
      "kNumber": "K081249",
      "deviceName": "DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM",
      "productCode": "DEB",
      "decisionDate": "2008-07-21",
      "reviewDays": 80
    },
    {
      "kNumber": "K071603",
      "deviceName": "DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)",
      "productCode": "DHX",
      "decisionDate": "2008-06-25",
      "reviewDays": 379
    },
    {
      "kNumber": "K071597",
      "deviceName": "DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600",
      "productCode": "LOJ",
      "decisionDate": "2008-06-04",
      "reviewDays": 358
    },
    {
      "kNumber": "K073604",
      "deviceName": "DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD",
      "productCode": "CEC",
      "decisionDate": "2008-03-13",
      "reviewDays": 83
    },
    {
      "kNumber": "K073561",
      "deviceName": "DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR",
      "productCode": "CFN",
      "decisionDate": "2008-02-26",
      "reviewDays": 69
    },
    {
      "kNumber": "K073072",
      "deviceName": "DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B",
      "productCode": "JHM",
      "decisionDate": "2008-02-21",
      "reviewDays": 113
    },
    {
      "kNumber": "K073055",
      "deviceName": "DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270",
      "productCode": "JFY",
      "decisionDate": "2008-01-03",
      "reviewDays": 65
    },
    {
      "kNumber": "K072965",
      "deviceName": "DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON",
      "productCode": "DBA",
      "decisionDate": "2007-12-21",
      "reviewDays": 60
    }
  ],
  "nameVariants": {
    "total": "5",
    "shown": [
      {
        "name": "Dade Behring",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Dade Behring , Inc.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Dade Behring Inc",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Dade Behring, Inc.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Dade Behring, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Dade%20Behring%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Dade%20Behring%2C%20Inc.%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": "2026-08-11T14:48:53.023Z"
}