{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Indianapolis",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82139",
      "recalling_firm": "Roche Diagnostics Corporation",
      "address_1": "9115 Hague Rd",
      "address_2": "N/A",
      "postal_code": "46256-1025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Distribution to states of: AL, AZ, CA, GA, IA, MO, NJ, NY, SC, TN and TX.",
      "recall_number": "Z-1368-2019",
      "product_description": "Cobas¿ infinity central lab IT solution   Material Number: 07154003001     Calculator/Data Processing Module, For Clinical Use",
      "product_quantity": "15 units",
      "reason_for_recall": "Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.",
      "recall_initiation_date": "20190204",
      "center_classification_date": "20190517",
      "termination_date": "20200916",
      "report_date": "20190529",
      "code_info": "Software versions 2.0 thorough 2.5  Serial Numbers:  81191  81371  81385  81465  81469  81470  81481  81485  81527  81528  81618  81628  81652  81655  81662"
    }
  ]
}