{
  "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,
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  "results": [
    {
      "country": "United States",
      "city": "Indianapolis",
      "address_1": "9115 Hague Rd",
      "reason_for_recall": "A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.",
      "address_2": "",
      "product_quantity": "255 instruments",
      "code_info": "none",
      "center_classification_date": "20180201",
      "distribution_pattern": "Nationwide Distribution",
      "state": "IN",
      "product_description": "Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244  - Elecsys 2010    Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.",
      "report_date": "20180207",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Roche Diagnostics Corporation",
      "recall_number": "Z-0499-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "78756",
      "termination_date": "20190430",
      "more_code_info": "",
      "recall_initiation_date": "20170705",
      "postal_code": "46256-1025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}