{
  "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": "88398",
      "recalling_firm": "Roche Diagnostics Operations, Inc.",
      "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 Nationwide distribution",
      "recall_number": "Z-2444-2021",
      "product_description": "cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001",
      "product_quantity": "2058 licenses worldwide, 79 licenses in US",
      "reason_for_recall": "Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the \"correct\" result would still be available on the instrument.",
      "recall_initiation_date": "20210624",
      "center_classification_date": "20210910",
      "termination_date": "20230721",
      "report_date": "20210922",
      "code_info": "UDI: 04015630936007;  All systems running software version 3.01.03 - 3.02.08",
      "more_code_info": ""
    }
  ]
}