{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "115082",
      "product_res_number": "Z-0665-2013",
      "event_date_initiated": "2012-12-06",
      "event_date_posted": "2013-01-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-12-24",
      "res_event_number": "63941",
      "product_code": "DKB",
      "k_numbers": [
        "K790735"
      ],
      "product_description": "Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL\n\nThe Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and benzodiazepines in human serum.",
      "code_info": "Lot D1",
      "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": "800-441-9250",
      "reason_for_recall": "Incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators.  The correct expiration date is 2013-12-31.  The incorrect assigned expiration date is 2014-12-31.",
      "root_cause_description": "Error in labeling",
      "action": "Siemens sent a Customer Notification letter dated December 2012 to all affected customers of Emit(R) tox(TM) Serum Calibrators lot D1, informing them that Siemens Healthcare Diagnostics, Inc. has confirmed that the expiration of 2014-12-31 is incorrect.  Siemens requested customers to discontinue use and discard any remaining inventory of the D1 lots.  Customers were instructed to complete the Effectiveness Check form included with the letter even if no replacement reagents were needed and fax to 302-631-8467.   Siemens would replace any unused kits of the affected lots at no charge.\nCustomers with questions were instructed to contact their Siemens Technical Solutions Center or their local Siemens technical support representative.\nFor questions regarding this recall call 302-631-6311.",
      "product_quantity": "1,998 cartons",
      "distribution_pattern": "Nationwide Distribution to the following states:  AL, AR, CA, CO, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NY, OH, PA, TN, TX and WI.",
      "openfda": {
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          "K021393",
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          "K963191",
          "K962817",
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          "K842386",
          "K833276",
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          "K051088",
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          "K936028",
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          "K950139",
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          "K913740",
          "K913741",
          "K923340",
          "K032574",
          "K954608",
          "K990255",
          "K981403",
          "K875216",
          "K902578",
          "K062162",
          "K872392",
          "K913739",
          "K033879",
          "K133710",
          "K932754",
          "K012318",
          "K915003",
          "K892332",
          "K101752",
          "K821767",
          "K862403"
        ],
        "registration_number": [
          "2432235",
          "1319808",
          "2050012",
          "3003610499",
          "3010939897",
          "1827821",
          "3002642396",
          "3002809144",
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          "2517506",
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          "3012963943",
          "2030861",
          "3004493545",
          "2020952",
          "9610529",
          "3003795116",
          "3033967997"
        ],
        "fei_number": [
          "2432235",
          "3002806559",
          "2050012",
          "3003610499",
          "3010939897",
          "1827821",
          "3002642396",
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          "3012963943",
          "3004493545",
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          "3003795116",
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        ],
        "device_name": "Calibrators, Drug Mixture",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3200",
        "device_class": "2"
      }
    }
  ]
}