{
  "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": [
    {
      "status": "Terminated",
      "city": "Indianapolis",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79805",
      "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 the states of :  CA, CT, IA, IN, KY, ME, MI, NC, NY, OH, SC, TX, and VA.",
      "recall_number": "Z-2136-2018",
      "product_description": "cobas e 801 immunoassay analyzer, cobas 8000 Modular Series    The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.",
      "product_quantity": "35",
      "reason_for_recall": "The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.",
      "recall_initiation_date": "20180403",
      "center_classification_date": "20180610",
      "termination_date": "20191121",
      "report_date": "20180620",
      "code_info": "Serial numbers: 1744-08  1744-09  1744-10  1758-08  1606-09  1752-05  1752-06  1630-08  1738-01  1744-07  1758-09  1759-04  1758-06  1758-07  1743-09  1743-10  1752-04  1759-05  17C5-06  17C5-07  1615-08  1612-10  17C5-09  1744-05  1744-06  1743-07  1743-08  1744-03  1744-04  1759-06  17C5-05  17C5-08  17C5-10  17C6-01  17C6-02"
    }
  ]
}