{
  "companyId": "47671",
  "slug": "siemens-healthcare-diagnostics-inc-47671",
  "name": "Siemens Healthcare Diagnostics, Inc.",
  "clearances": {
    "total": 244,
    "last12Months": 6,
    "first": "2008-05-16",
    "latest": "2026-07-24"
  },
  "medianReviewDays": 108,
  "productCodeCount": 96,
  "recalls": {
    "total": 765,
    "openLast12Months": 14,
    "recent": [
      {
        "resNumber": "Z-2890-2026",
        "productCode": "JIR",
        "status": "Open, Classified",
        "recallClass": null,
        "initiated": "2026-07-06",
        "reason": "processing Atellica CH Urine Albumin (UAlb)\r\ntests on Atellica CH and Atellica CI analyzers may lead to the following issues: Falsely\r\ndepressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH\r\nEnzymatic Hemoglobin A1c (A1c_E) results; and Increased rate of reaction cuvette QC\r\nfailures and Delayed results due to QC failures."
      },
      {
        "resNumber": "Z-2880-2026",
        "productCode": "KLR",
        "status": "Open, Classified",
        "recallClass": null,
        "initiated": "2026-06-26",
        "reason": "Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated."
      },
      {
        "resNumber": "Z-2881-2026",
        "productCode": "LFG",
        "status": "Open, Classified",
        "recallClass": null,
        "initiated": "2026-06-26",
        "reason": "out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated."
      },
      {
        "resNumber": "Z-2703-2026",
        "productCode": "PDJ",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-06-08",
        "reason": "The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results."
      },
      {
        "resNumber": "Z-2398-2026",
        "productCode": "MLM",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-05-07",
        "reason": "A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge."
      }
    ]
  },
  "registration": {
    "sites": 5,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "JJX",
      "deviceName": "Single (Specified) Analyte Controls (Assayed And Unassayed)",
      "clearances": 34,
      "latest": "2015-07-17",
      "medianReviewDays": 35
    },
    {
      "code": "JIX",
      "deviceName": "Calibrator, Multi-Analyte Mixture",
      "clearances": 12,
      "latest": "2015-12-18",
      "medianReviewDays": 60
    },
    {
      "code": "JIT",
      "deviceName": "Calibrator, Secondary",
      "clearances": 11,
      "latest": "2016-11-17",
      "medianReviewDays": 66
    },
    {
      "code": "JLW",
      "deviceName": "Radioimmunoassay, Thyroid-Stimulating Hormone",
      "clearances": 10,
      "latest": "2026-02-06",
      "medianReviewDays": 142
    },
    {
      "code": "DHB",
      "deviceName": "System, Test, Radioallergosorbent (Rast) Immunological",
      "clearances": 9,
      "latest": "2014-05-28",
      "medianReviewDays": 128
    },
    {
      "code": "LTT",
      "deviceName": "Panels, Test, Susceptibility, Antimicrobial",
      "clearances": 6,
      "latest": "2015-07-02",
      "medianReviewDays": 84
    },
    {
      "code": "MMI",
      "deviceName": "Immunoassay Method, Troponin Subunit",
      "clearances": 6,
      "latest": "2024-07-25",
      "medianReviewDays": 90
    },
    {
      "code": "CDZ",
      "deviceName": "Radioimmunoassay, Testosterones And Dihydrotestosterone",
      "clearances": 5,
      "latest": "2019-08-28",
      "medianReviewDays": 205
    },
    {
      "code": "CEC",
      "deviceName": "Radioimmunoassay, Free Thyroxine",
      "clearances": 5,
      "latest": "2014-11-26",
      "medianReviewDays": 198
    },
    {
      "code": "CGX",
      "deviceName": "Alkaline Picrate, Colorimetry, Creatinine",
      "clearances": 4,
      "latest": "2024-12-04",
      "medianReviewDays": 89
    },
    {
      "code": "DAP",
      "deviceName": "Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control",
      "clearances": 4,
      "latest": "2011-05-16",
      "medianReviewDays": 121
    },
    {
      "code": "DJG",
      "deviceName": "Enzyme Immunoassay, Opiates",
      "clearances": 4,
      "latest": "2023-07-25",
      "medianReviewDays": 175
    },
    {
      "code": "LRG",
      "deviceName": "Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems",
      "clearances": 4,
      "latest": "2011-08-04",
      "medianReviewDays": 82
    },
    {
      "code": "MRG",
      "deviceName": "System, Test, Vitamin D",
      "clearances": 4,
      "latest": "2020-05-29",
      "medianReviewDays": 212
    },
    {
      "code": "CDD",
      "deviceName": "Radioassay, Vitamin B12",
      "clearances": 3,
      "latest": "2014-01-02",
      "medianReviewDays": 80
    },
    {
      "code": "CEW",
      "deviceName": "Radioimmunoassay, Parathyroid Hormone",
      "clearances": 3,
      "latest": "2017-05-23",
      "medianReviewDays": 151
    },
    {
      "code": "CGS",
      "deviceName": "Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes",
      "clearances": 3,
      "latest": "2016-09-07",
      "medianReviewDays": 95
    },
    {
      "code": "CIG",
      "deviceName": "Diazo Colorimetry, Bilirubin",
      "clearances": 3,
      "latest": "2026-02-27",
      "medianReviewDays": 245
    },
    {
      "code": "GKZ",
      "deviceName": "Counter, Differential Cell",
      "clearances": 3,
      "latest": "2017-08-11",
      "medianReviewDays": 435
    },
    {
      "code": "JGS",
      "deviceName": "Electrode, Ion Specific, Sodium",
      "clearances": 3,
      "latest": "2023-07-25",
      "medianReviewDays": 234
    },
    {
      "code": "LCP",
      "deviceName": "Assay, Glycosylated Hemoglobin",
      "clearances": 3,
      "latest": "2014-01-24",
      "medianReviewDays": 259
    },
    {
      "code": "LOL",
      "deviceName": "Hepatitis A Test (Antibody And Igm Antibody)",
      "clearances": 3,
      "latest": "2016-10-13",
      "medianReviewDays": 71
    },
    {
      "code": "MOI",
      "deviceName": "System, Test, Immunological, Antigen, Tumor",
      "clearances": 3,
      "latest": "2020-02-13",
      "medianReviewDays": 58
    },
    {
      "code": "NBC",
      "deviceName": "Test, Natriuretic Peptide",
      "clearances": 3,
      "latest": "2023-09-24",
      "medianReviewDays": 74
    },
    {
      "code": "PDJ",
      "deviceName": "Hemoglobin A1c Test System",
      "clearances": 3,
      "latest": "2021-07-02",
      "medianReviewDays": 203
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "96",
  "recentClearances": [
    {
      "kNumber": "K261364",
      "deviceName": "Atellica CH Acetaminophen 2 (ACTM)",
      "productCode": "LDP",
      "decisionDate": "2026-07-24",
      "reviewDays": 88
    },
    {
      "kNumber": "K251998",
      "deviceName": "Atellica CH Diazo Total Bilirubin (D_TBil)",
      "productCode": "CIG",
      "decisionDate": "2026-02-27",
      "reviewDays": 245
    },
    {
      "kNumber": "K251543",
      "deviceName": "Atellica® IM TSH3-Ultra II (TSH3ULII)",
      "productCode": "JLW",
      "decisionDate": "2026-02-06",
      "reviewDays": 262
    },
    {
      "kNumber": "K251630",
      "deviceName": "Atellica IM Total PSA II (tPSAII)",
      "productCode": "LTJ",
      "decisionDate": "2026-01-05",
      "reviewDays": 222
    },
    {
      "kNumber": "K250816",
      "deviceName": "ADVIA Centaur Anti-Thyroglobulin II (aTgII)",
      "productCode": "JNL",
      "decisionDate": "2025-12-04",
      "reviewDays": 261
    },
    {
      "kNumber": "K250250",
      "deviceName": "ADVIA Centaur Anti-Thyroid Peroxidase II",
      "productCode": "JZO",
      "decisionDate": "2025-10-17",
      "reviewDays": 262
    },
    {
      "kNumber": "K242981",
      "deviceName": "Atellica IM Thyroglobulin (Tg)",
      "productCode": "MSW",
      "decisionDate": "2025-06-20",
      "reviewDays": 267
    },
    {
      "kNumber": "K243570",
      "deviceName": "Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)",
      "productCode": "JLW",
      "decisionDate": "2025-04-25",
      "reviewDays": 158
    },
    {
      "kNumber": "K242685",
      "deviceName": "Atellica® CH Creatinine_3 (Crea3)",
      "productCode": "CGX",
      "decisionDate": "2024-12-04",
      "reviewDays": 89
    },
    {
      "kNumber": "K241800",
      "deviceName": "Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)",
      "productCode": "MRR",
      "decisionDate": "2024-07-26",
      "reviewDays": 35
    }
  ],
  "nameVariants": {
    "total": "18",
    "shown": [
      {
        "name": "SIEMENS HEALTHCARE DIAGNOSTICS INC",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "SIEMENS HEALTHCARE DIAGNOSTICS INC",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "SIEMENS HEALTHCARE DIAGNOSTICS INC.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Siemens Healthcare Diagnostics",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Siemens Healthcare Diagnostics",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Siemens Healthcare Diagnostics",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Siemens Healthcare Diagnostics Inc",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Siemens Healthcare Diagnostics Inc",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Siemens%20Healthcare%20Diagnostics%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Siemens%20Healthcare%20Diagnostics%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": "2026-08-11T14:48:53.027Z"
}