{
  "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": "Durham",
      "address_1": "3210 E Nc Hwy 54",
      "reason_for_recall": "Customers complained of low/empty reagent vials.",
      "address_2": "",
      "product_quantity": "637 boxes x 10 vials",
      "code_info": "Lot No. 21929007",
      "center_classification_date": "20161023",
      "distribution_pattern": "Nationwide Distribution -- AR, CA, DC, GA, HI, ID, IL, IN, LA, ME, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV.",
      "state": "NC",
      "product_description": "ex-TEM Assay for ROTEM delta Thromboelastometry System.  Art. no.: 503-05 US, ex-tem.    Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.",
      "report_date": "20161102",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "TEM Systems Inc",
      "recall_number": "Z-0302-2017",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "75265",
      "termination_date": "20171205",
      "more_code_info": "",
      "recall_initiation_date": "20160913",
      "postal_code": "27709",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}