{
  "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": "658 units",
      "code_info": "ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent - SMN# 10377503, Lot # 334018",
      "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": "ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on the ADVIA¿ Chemistry Systems.  Copies of IFUs included in submission.",
      "report_date": "20160803",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "recall_number": "Z-2299-2016",
      "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"
    }
  ]
}