{
  "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": "Indianapolis",
      "address_1": "9115 Hague Rd",
      "reason_for_recall": "Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data Management Systems (DMS). The issue can lead to the data loss or in the worst case to an erroneous assignment of the patient data (patient mismatch). The issue will only occur at sites using POTCT1-A communication via USB.",
      "address_2": "",
      "product_quantity": "US 5,604 devices, OUS 91,925",
      "code_info": "Model/Catalog/Part Number: 05060290001; serial numbers: UU41000000 through UU41064963 and UU41064964 through  UU41122741.",
      "center_classification_date": "20160314",
      "distribution_pattern": "Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, and WV.",
      "state": "IN",
      "product_description": "Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System  Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be use with single-use, auto-disabling lancing devices.",
      "report_date": "20160323",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Roche Diagnostics Operations, Inc.",
      "recall_number": "Z-1172-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "73253",
      "termination_date": "20170530",
      "more_code_info": "",
      "recall_initiation_date": "20160211",
      "postal_code": "46256-1025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}