{
  "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": [
    {
      "status": "Terminated",
      "city": "Sunnyvale",
      "state": "CA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "67607",
      "recalling_firm": "Lin-Zhi International Inc",
      "address_1": "670 Almanor Ave",
      "address_2": "N/A",
      "postal_code": "94085-3513",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Distribution including CA.",
      "recall_number": "Z-1270-2014",
      "product_description": "Single Analyte DAU Calibrator (5 mL)  Norbuprenorphine: Cutoff Calibrator;  IVD - for in vitro diagnostic use only;  Lin-Zhi International  Sunnyvale, CA    The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer",
      "product_quantity": "120 units, 60 of each lot number",
      "reason_for_recall": "Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL).",
      "recall_initiation_date": "20140218",
      "center_classification_date": "20140321",
      "termination_date": "20140425",
      "report_date": "20140402",
      "code_info": "Product catalog number: A68827;  Lots 1308006, 1308131, Expiry: March 28, 2015."
    }
  ]
}