{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "130895",
      "product_res_number": "Z-0417-2015",
      "event_date_initiated": "2014-10-16",
      "event_date_posted": "2015-09-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-09-03",
      "res_event_number": "69545",
      "product_code": "JZH",
      "product_description": "MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test.  In vitro diagnostic.",
      "code_info": "Model Number A027; Lot Number 018186;  (self-affixed, EDMA Code: 12 01 02 04 00; Complement Component Bb)",
      "firm_fei_number": "1000122536",
      "recalling_firm": "Diagnostic Hybrids Inc",
      "address_1": "1055 E State St",
      "address_2": "Suite 100",
      "city": "Athens",
      "state": "OH",
      "postal_code": "45701-7911",
      "additional_info_contact": "740-589-3300",
      "reason_for_recall": "Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.",
      "root_cause_description": "Device Design",
      "action": "Quidel sent an Urgent Medical Device Recall letter dated October 16, 2014, to all consignees.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed to immediately review their inventory and determine if they have of the affected product.  If so, they should remove it from their inventory and destroy it immediately by discarding it into their normal biomedical waste stream.  \nComplete the enclosed Certificate of Destruction.  Upon receipt of the Certificate of Destruction, Quidel, will then schedule their shipment of replacement product.  \nIf consignees further distributed the affected product, they should identify the customers and provide them with the Urgent Medical Device Recall. \nConsignees were instructed to monitor and reconcile the quarantine of product with the customers as this information may need to be provided to the authorities.  \nFor questions regarding this recall call 740-589-3300.\nFor technical support consignees should contact technicalsupport@quidel.com or call 800-874-1517.",
      "product_quantity": "171",
      "distribution_pattern": "Worldwide Distribution - USA, including AL, CO, CT, FL, KY, MN, NC, NV, OH, PA, and WA; and, the countries of Canada, China, India, and Switzerland.",
      "openfda": {
        "k_number": [
          "K831959",
          "K964843",
          "K772084",
          "K882623",
          "K811740",
          "K781016"
        ],
        "device_name": "Factor B, Antigen, Antiserum, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5320",
        "device_class": "2",
        "registration_number": [
          "1528450",
          "2050010",
          "3019906",
          "2050012",
          "3014325803"
        ],
        "fei_number": [
          "2050010",
          "1000122536",
          "3019906",
          "2050012",
          "3014325803"
        ]
      }
    }
  ]
}