{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "149847",
      "product_res_number": "Z-0302-2017",
      "event_date_initiated": "2016-09-13",
      "event_date_created": "2016-10-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-12-05",
      "res_event_number": "75265",
      "product_code": "JPA",
      "k_numbers": [
        "K101533"
      ],
      "product_description": "ex-TEM Assay for ROTEM delta Thromboelastometry System.  Art. no.: 503-05 US, ex-tem.\n\nUsed to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.",
      "code_info": "Lot No. 21929007",
      "firm_fei_number": "3008366794",
      "recalling_firm": "TEM Systems Inc",
      "address_1": "3210 E Nc Hwy 54",
      "city": "Durham",
      "state": "NC",
      "postal_code": "27709",
      "additional_info_contact": "Rick Epps\n919-941-7777 Ext. 108",
      "reason_for_recall": "Customers complained of low/empty reagent vials.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Customers were notified of the recall by an Urgent Important Customer Information letter on 9/13/2016.  The letter described the device and the problem.  Customers were told to stop using the product and to call for replacement product.  The letter included a Confirmation of Compliance Letter which was to be completed and returned.",
      "product_quantity": "637 boxes x 10 vials",
      "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.",
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        "device_name": "System, Multipurpose For In Vitro Coagulation Studies",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5425",
        "device_class": "2"
      }
    }
  ]
}