{
  "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": "111800",
      "product_res_number": "Z-0030-2013",
      "event_date_initiated": "2012-07-30",
      "event_date_posted": "2012-10-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-08-27",
      "res_event_number": "62832",
      "product_code": "DLZ",
      "k_numbers": [
        "K011528",
        "K913190"
      ],
      "product_description": "Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL)\n\nProduct Usage: Enzyme n Immunoassay, Phenobarbital",
      "code_info": "Emit(R) 2000 Phenobarbital Assay (OSR4D229), lots 1151, 1167, 1191, and/or 1212 and Syva(R) Emit(R) Phenobarbital Assay (4D019UL), lots D4, D5, D6, and D7",
      "firm_fei_number": "2517506",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 GBC Drive, Mailstop 514 500 GBC Drive Mailstop 514",
      "address_2": "PO BOX 6101",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19714-6101",
      "additional_info_contact": "302-631-6311",
      "reason_for_recall": "Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems.  Also, if the Syva(R) Emit(R) 2000 Phenobartbital Assay (4D019UL) lots D4, D5, D6, and/or D7 as an application on AU(R) Systems is used, the issue may be experienced.  Firm has found that within-run imprecison of the recalled lots when run on an AU(R) System may be higher that what would normally be obs",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Siemens sent an Urgent Field Safety notice letter dated July 2012 to all affected customers.  The letter identified the affected product, problem and actions to be taken.  Customers were instructed to immediately discontinue use and discard any remaining inventory of the affected product.  Customers were asked to share the content of the letter with laboratory director regarding the need to review previous Phenobarbital results, conduct patient follow up and/or repeat testing. For a no charge replacement of remaining inventory customers were instructed to contact Siemens Customer Service Center at  888-588-3916.  For questions contact Siemens Technical Solutions Center at 800-227-8994.",
      "product_quantity": "79,744 cartons",
      "distribution_pattern": "United States Nationwide Distribution in the states of: CA, FL, KS, MA, MN, MS, NM, NY, NC, OR, PA, TN, TX, UT, VA, and WA.",
      "openfda": {
        "k_number": [
          "K854607",
          "K000012",
          "K811621",
          "K864926",
          "K811367",
          "K842264",
          "K862308",
          "K874625",
          "K910355",
          "K860365",
          "K896861",
          "K913190",
          "K942501",
          "K946210",
          "K935568",
          "K852995",
          "K984288",
          "K071644",
          "K833796",
          "K993031",
          "K943981",
          "K834216",
          "K011303",
          "K852946",
          "K802039",
          "K123271",
          "K011528",
          "K770919",
          "K944932",
          "K884419",
          "K832097",
          "K860046",
          "K210858",
          "K081231",
          "K832457"
        ],
        "registration_number": [
          "2432235",
          "1319809",
          "2050012",
          "3010939897",
          "3002642396",
          "3002809144",
          "3006198300",
          "1219913",
          "3011989923",
          "9610126",
          "3003561301",
          "1181121",
          "9680746",
          "2517506",
          "3003871639",
          "3000308930",
          "1319681",
          "3005333358",
          "2050010",
          "3012963943",
          "3004493545",
          "1319436",
          "9610529",
          "3010825766",
          "3003795116"
        ],
        "fei_number": [
          "2432235",
          "1000120319",
          "3002806559",
          "1000206808",
          "2050012",
          "3010939897",
          "3002642396",
          "3002809144",
          "3006198300",
          "1219913",
          "3011989923",
          "3003561301",
          "3002806560",
          "1181121",
          "1000136573",
          "2517506",
          "3003871639",
          "1000305840",
          "3000308930",
          "3005333358",
          "2050010",
          "3012963943",
          "3004493545",
          "3010825766",
          "3003795116"
        ],
        "device_name": "Enzyme Immunoassay, Phenobarbital",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3660",
        "device_class": "2"
      }
    }
  ]
}