{
  "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": [
    {
      "status": "Terminated",
      "city": "Durham",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73357",
      "recalling_firm": "TEM Systems Inc",
      "address_1": "3210 E Nc Hwy 54",
      "address_2": "N/A",
      "postal_code": "27709",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed in the states of AZ, AR, CA, FL, GA, HI, ID, IL, IN, LA, MD, MA, MN, MO, NE, NJ, NM, NY, PA, OH, SC, SD, TN, TX, UT, WA, WV and the country of Germany.",
      "recall_number": "Z-1090-2016",
      "product_description": "ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only.  Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.",
      "product_quantity": "476 boxes x 5 vials",
      "reason_for_recall": "Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm is July 2016.",
      "recall_initiation_date": "20160218",
      "center_classification_date": "20160309",
      "termination_date": "20160630",
      "report_date": "20160316",
      "code_info": "Lot 41925401"
    }
  ]
}