{
  "companyId": "48761",
  "slug": "microgenics-corporation-48761",
  "name": "Microgenics Corporation",
  "clearances": {
    "total": 126,
    "last12Months": 0,
    "first": "1985-07-22",
    "latest": "2024-12-11"
  },
  "medianReviewDays": 76,
  "productCodeCount": 43,
  "recalls": {
    "total": 14,
    "openLast12Months": 1,
    "recent": [
      {
        "resNumber": "Z-0415-2026",
        "productCode": "JJY",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-10-01",
        "reason": "The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays."
      },
      {
        "resNumber": "Z-1284-2022",
        "productCode": "MLM",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2022-01-20",
        "reason": "Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay."
      },
      {
        "resNumber": "Z-0008-2017",
        "productCode": "OUF",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2016-08-15",
        "reason": "A reagent stability issue (still under investigation) causes less separation in the calibration curve, which affects results across the entire range.  For controls, maximum bias of +/- 35% for low levels, +/- 33% for mid-range levels, and +/- 47% for high levels is observed.  Bias in patient samples ranges from -15.7% to +5.2% with an average bias of -5.6% when comparing the QMS everolimus assay to an everolimus LC-MS reference method.  Patient samples across the measuring range  sub-therapeutic, therapeutic, and supra-therapeutic  could be affected."
      },
      {
        "resNumber": "Z-2884-2016",
        "productCode": "DKJ",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2016-07-25",
        "reason": "Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL."
      },
      {
        "resNumber": "Z-0501-2015",
        "productCode": "JJY",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2014-10-20",
        "reason": "MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kinase-MB (CK-MB) and B-Type Natriuretic Peptide-32 (BNP-32)."
      }
    ]
  },
  "registration": {
    "sites": 1,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "DJG",
      "deviceName": "Enzyme Immunoassay, Opiates",
      "clearances": 13,
      "latest": "2023-09-27",
      "medianReviewDays": 134
    },
    {
      "code": "KXT",
      "deviceName": "Enzyme Immunoassay, Digoxin",
      "clearances": 9,
      "latest": "1994-06-13",
      "medianReviewDays": 59
    },
    {
      "code": "DKZ",
      "deviceName": "Enzyme Immunoassay, Amphetamine",
      "clearances": 8,
      "latest": "2024-10-30",
      "medianReviewDays": 120
    },
    {
      "code": "JXM",
      "deviceName": "Enzyme Immunoassay, Benzodiazepine",
      "clearances": 7,
      "latest": "2024-12-11",
      "medianReviewDays": 55
    },
    {
      "code": "DIO",
      "deviceName": "Enzyme Immunoassay, Cocaine And Cocaine Metabolites",
      "clearances": 6,
      "latest": "2021-09-24",
      "medianReviewDays": 80
    },
    {
      "code": "DKB",
      "deviceName": "Calibrators, Drug Mixture",
      "clearances": 6,
      "latest": "2012-12-13",
      "medianReviewDays": 87
    },
    {
      "code": "JJY",
      "deviceName": "Multi-Analyte Controls, All Kinds (Assayed)",
      "clearances": 6,
      "latest": "2012-08-31",
      "medianReviewDays": 32
    },
    {
      "code": "KLI",
      "deviceName": "Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine",
      "clearances": 6,
      "latest": "1994-10-20",
      "medianReviewDays": 58
    },
    {
      "code": "DLJ",
      "deviceName": "Calibrators, Drug Specific",
      "clearances": 5,
      "latest": "2003-02-10",
      "medianReviewDays": 52
    },
    {
      "code": "LAS",
      "deviceName": "Drug Specific Control Materials",
      "clearances": 5,
      "latest": "2005-06-06",
      "medianReviewDays": 40
    },
    {
      "code": "LDJ",
      "deviceName": "Enzyme Immunoassay, Cannabinoids",
      "clearances": 5,
      "latest": "2011-04-08",
      "medianReviewDays": 77
    },
    {
      "code": "DIS",
      "deviceName": "Enzyme Immunoassay, Barbiturate",
      "clearances": 4,
      "latest": "1994-12-28",
      "medianReviewDays": 95
    },
    {
      "code": "CGN",
      "deviceName": "Acid, Folic, Radioimmunoassay",
      "clearances": 3,
      "latest": "1995-06-29",
      "medianReviewDays": 69
    },
    {
      "code": "DIF",
      "deviceName": "Drug Mixture Control Materials",
      "clearances": 3,
      "latest": "2011-03-24",
      "medianReviewDays": 64
    },
    {
      "code": "LAF",
      "deviceName": "Gas Chromatography, Methamphetamine",
      "clearances": 3,
      "latest": "2011-04-08",
      "medianReviewDays": 97
    },
    {
      "code": "LCM",
      "deviceName": "Enzyme Immunoassay, Phencyclidine",
      "clearances": 3,
      "latest": "2011-04-08",
      "medianReviewDays": 133
    },
    {
      "code": "CDD",
      "deviceName": "Radioassay, Vitamin B12",
      "clearances": 2,
      "latest": "1995-07-11",
      "medianReviewDays": 29
    },
    {
      "code": "CGR",
      "deviceName": "Radioimmunoassay, Cortisol",
      "clearances": 2,
      "latest": "1990-04-03",
      "medianReviewDays": 14
    },
    {
      "code": "DJR",
      "deviceName": "Enzyme Immunoassay, Methadone",
      "clearances": 2,
      "latest": "2003-08-27",
      "medianReviewDays": 67
    },
    {
      "code": "KLT",
      "deviceName": "Enzyme Immunoassay, Carbamazepine",
      "clearances": 2,
      "latest": "2013-06-05",
      "medianReviewDays": 78
    },
    {
      "code": "LFH",
      "deviceName": "U.V. Spectrometry, Tricyclic Antidepressant Drugs",
      "clearances": 2,
      "latest": "2023-11-17",
      "medianReviewDays": 221
    },
    {
      "code": "MLM",
      "deviceName": "Enzyme Immunoassay, Tracrolimus",
      "clearances": 2,
      "latest": "2013-07-11",
      "medianReviewDays": 46
    },
    {
      "code": "OUF",
      "deviceName": "Everolimus Immunoassay",
      "clearances": 2,
      "latest": "2013-08-20",
      "medianReviewDays": 344
    },
    {
      "code": "CDP",
      "deviceName": "Radioimmunoassay, Total Triiodothyronine",
      "clearances": 1,
      "latest": "1990-09-27",
      "medianReviewDays": 21
    },
    {
      "code": "DIP",
      "deviceName": "Enzyme Immunoassay, Diphenylhydantoin",
      "clearances": 1,
      "latest": "1991-01-17",
      "medianReviewDays": 29
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "43",
  "recentClearances": [
    {
      "kNumber": "K243498",
      "deviceName": "Alinity c Benzodiazepines Reagent Kit",
      "productCode": "JXM",
      "decisionDate": "2024-12-11",
      "reviewDays": 29
    },
    {
      "kNumber": "K240670",
      "deviceName": "DRI Ecstasy Plus Assay",
      "productCode": "DKZ",
      "decisionDate": "2024-10-30",
      "reviewDays": 233
    },
    {
      "kNumber": "K231020",
      "deviceName": "Alinity c Tricyclic Antidepressants Reagent Kit",
      "productCode": "LFH",
      "decisionDate": "2023-11-17",
      "reviewDays": 221
    },
    {
      "kNumber": "K231007",
      "deviceName": "CEDIA Heroin Metabolite (6-AM) Assay",
      "productCode": "DJG",
      "decisionDate": "2023-09-27",
      "reviewDays": 173
    },
    {
      "kNumber": "K213875",
      "deviceName": "DRI TM Tricyclics Serum Tox Assay",
      "productCode": "LFH",
      "decisionDate": "2022-12-21",
      "reviewDays": 373
    },
    {
      "kNumber": "K211973",
      "deviceName": "DRI Cocaine Metabolite Assay",
      "productCode": "DIO",
      "decisionDate": "2021-09-24",
      "reviewDays": 91
    },
    {
      "kNumber": "K192943",
      "deviceName": "CEDIA Heroin Metabolite (6-AM) assay",
      "productCode": "DJG",
      "decisionDate": "2019-12-16",
      "reviewDays": 59
    },
    {
      "kNumber": "K190968",
      "deviceName": "CEDIA Benzodiazepine Assay",
      "productCode": "JXM",
      "decisionDate": "2019-12-09",
      "reviewDays": 241
    },
    {
      "kNumber": "K181499",
      "deviceName": "DRI Cocaine Metabolite Assay",
      "productCode": "DIO",
      "decisionDate": "2018-07-06",
      "reviewDays": 29
    },
    {
      "kNumber": "K173963",
      "deviceName": "DRI Benzodiazepine Assay",
      "productCode": "JXM",
      "decisionDate": "2018-02-21",
      "reviewDays": 55
    }
  ],
  "nameVariants": {
    "total": "7",
    "shown": [
      {
        "name": "Microgenics Corp",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Microgenics Corp",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Microgenics Corp.",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Microgenics Corporation",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Microgenics Corporation",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Microgenics Corporation",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Microgenics Corporation",
        "dataset": "device/recall",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Microgenics%20Corporation%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Microgenics%20Corporation%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": "2026-08-11T14:48:53.037Z"
}