{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Newark",
      "address_1": "500 GBC Drive, Mailstop 514",
      "reason_for_recall": "Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL)  lots E1, E2, and E3 as an application if the AU(R) System is used, the issue may be experienced.  Firm has found that within-run imprecision of the recalled lots frequency of outliers that differ from the expected value by 20%.  This is an expansion of",
      "address_2": "PO BOX 6101",
      "product_quantity": "1979 cartons",
      "code_info": "Emit(R) 2000 Phenobarbital Assay (OSR4D229) lots 1237 and 1264 and/or Syva(R) Emit(R) Phenobarbital Assay (4D019UL), lots E1, E2, and E3.",
      "center_classification_date": "20130110",
      "distribution_pattern": "Distributed in the states of CA, FL, IL, KS, MA, MI, MN, MS, NM, NY, NC, OH, OR, PA, TN, TX, UT, and WA.",
      "state": "DE",
      "product_description": "Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL).    Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma.",
      "report_date": "20130116",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "recall_number": "Z-0664-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "63892",
      "termination_date": "20140827",
      "more_code_info": "",
      "recall_initiation_date": "20121210",
      "postal_code": "19714-6101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}