{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Indianapolis",
      "address_1": "9115 Hague Rd",
      "reason_for_recall": "The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a consequence, vitamin D deficiency may develop over time.",
      "address_2": "",
      "product_quantity": "3591 units",
      "code_info": "No specific lot codes. This issue affects users of the MODULAR ANALYTICS E 170 module, cobas e 411 analyzer, and cobas e 601 and 602 modules",
      "center_classification_date": "20180708",
      "distribution_pattern": "US Nationwide distribution.",
      "state": "IN",
      "product_description": "Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160    Product Usage:  This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the immunoassay analyzer.",
      "report_date": "20180718",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Roche Diagnostics Corporation",
      "recall_number": "Z-2390-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "80008",
      "termination_date": "20200511",
      "more_code_info": "",
      "recall_initiation_date": "20180427",
      "postal_code": "46256-1025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}