{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "121917",
      "product_res_number": "Z-0181-2014",
      "event_date_initiated": "2013-08-30",
      "event_date_posted": "2013-11-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-08-27",
      "res_event_number": "66267",
      "product_code": "DLZ",
      "k_numbers": [
        "K011528",
        "K913190"
      ],
      "product_description": "Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay",
      "code_info": "Lots: E5-E7, F1-F5, 1290, 1300, 1313, 1330, 1338, 1367, 1371, and 1380.",
      "firm_fei_number": "2517506",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 Gbc Dr Ms 514",
      "address_2": "PO BOX 6101",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19702-2466",
      "additional_info_contact": "Siemens Diagnostics Customer Serv.\n800-441-9250",
      "reason_for_recall": "Imprecision with certain lots",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Siemens sent an Urgent Medical Device Recall letter dated August 2013.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed to immediately cease use of the affected product.  Siemens will replace unused affected product at no charge.   For replacements customers were instructed to incude this information on the Effectiveness Check form included with the letter.  The Effectiveness Check form must be returned even if no replacement reagents are needed.  The recall letter was to be retained with customers laboratory records and forwarded to those who may have received this product.  Customers with questions were instructed to contact Siemens Technical Solutions or their Siemens technical support representative.\nFor questions regarding this recall call 800-441-9250.",
      "product_quantity": "4963",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Mexico.",
      "openfda": {
        "k_number": [
          "K874625",
          "K943981",
          "K011303",
          "K842264",
          "K011528",
          "K123271",
          "K993031",
          "K000012",
          "K913190",
          "K833796",
          "K935568",
          "K811621",
          "K852995",
          "K864926",
          "K942501",
          "K832097",
          "K884419",
          "K081231",
          "K862308",
          "K910355",
          "K852946",
          "K071644",
          "K210858",
          "K860365",
          "K811367",
          "K944932",
          "K984288",
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          "K834216",
          "K854607",
          "K802039",
          "K946210",
          "K896861",
          "K770919",
          "K860046"
        ],
        "registration_number": [
          "3003795116",
          "9610529",
          "1319809",
          "3010939897",
          "3002809144",
          "2432235",
          "3010825766",
          "2050012",
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          "3011989923",
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          "3003871639",
          "9680746",
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          "1319436",
          "2517506",
          "3006198300"
        ],
        "fei_number": [
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          "3010939897",
          "3002809144",
          "2432235",
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          "3002806560",
          "3004493545",
          "1000136573",
          "2517506",
          "3006198300",
          "3002806559"
        ],
        "device_name": "Enzyme Immunoassay, Phenobarbital",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3660",
        "device_class": "2"
      }
    }
  ]
}