{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Newark",
      "address_1": "500 Gbc Dr Ms 514",
      "reason_for_recall": "Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on  a Beckman AU Clinical Chemistry System, and the ADVIA¿ Chemistry Theophylline_2 (THEO_2) reagent lot  334018, may exhibit increased imprecision for commercially available Bio-Rad Liquichek TDM Quality Control  Levels and patient samples.",
      "address_2": "PO BOX 6101",
      "product_quantity": "1,004 units",
      "code_info": "Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324  Syva¿ EMIT¿ 2000 Theophylline - kit lot G3",
      "center_classification_date": "20160728",
      "distribution_pattern": "Distributed to:               CA, CT, DE, FL, GA, IA, IN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, TN, VA, WA",
      "state": "DE",
      "product_description": "Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.",
      "report_date": "20160803",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "recall_number": "Z-2298-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "74524",
      "termination_date": "20170315",
      "recall_initiation_date": "20160617",
      "postal_code": "19702-2466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}