{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "115293",
      "product_res_number": "Z-0738-2013",
      "event_date_initiated": "2012-12-25",
      "event_date_posted": "2013-01-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-06-03",
      "res_event_number": "64054",
      "product_code": "MDB",
      "k_numbers": [
        "K020931"
      ],
      "product_description": "BacT/ALERT SA Blood Culture Bottle.\r\n\r\nThe BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.",
      "code_info": "Catalog Number: 259789, Lots/Batch: 1031866",
      "firm_fei_number": "3002769706",
      "recalling_firm": "bioMerieux, Inc.",
      "address_1": "100 Rodolphe St",
      "city": "Durham",
      "state": "NC",
      "postal_code": "27712-9402",
      "additional_info_contact": "Ryan LeMelle\n919-620-2599",
      "reason_for_recall": "BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "bioMerieux sent an \"URGENT PRODUCT REMOVAL NOTICE\" and Acknowledgement Form on January 4, 2013 to all affected customers.  The letter identified the product, problem, and actions to be taken by the customers.\r\nContact your local bioMerieux Customer Service Representative for additional assistance.",
      "product_quantity": "1690 cases",
      "distribution_pattern": "Worldwide Distribution.USA including the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WI, and WV, and the countries of China, Curacao and Japan.",
      "openfda": {
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        "registration_number": [
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          "3002769706",
          "3013718871",
          "3012421607",
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          "3003542872",
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        ],
        "device_name": "System, Blood Culturing",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2560",
        "device_class": "1"
      }
    }
  ]
}