{
  "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 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",
      "address_2": "PO BOX 6101",
      "product_quantity": "79,744 cartons",
      "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",
      "center_classification_date": "20121009",
      "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.",
      "state": "DE",
      "product_description": "Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL)    Product Usage: Enzyme n Immunoassay, Phenobarbital",
      "report_date": "20121017",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "recall_number": "Z-0030-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62832",
      "termination_date": "20140827",
      "recall_initiation_date": "20120730",
      "postal_code": "19714-6101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}