{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Tarrytown",
      "state": "N/A",
      "country": "Spain",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90867",
      "recalling_firm": "SIEMENS HEALTHCARE DIAGNOSTICS INC",
      "address_1": "511 Benedict Ave",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "Z-0094-2023",
      "product_description": "N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD\t\t\t  Siemens Material Number (SMN): 10446299",
      "product_quantity": "10,201 packs",
      "reason_for_recall": "N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).",
      "recall_initiation_date": "20220830",
      "center_classification_date": "20221014",
      "report_date": "20221026",
      "code_info": "UDI-DI:  0405686900179VF Lot Number:  153083; 153085; 153087A; 153090; 153095B; 153099A; 153004B.  Future lots may be impacted by the issue but will then be provided with a corresponding instruction note within the reagent package",
      "more_code_info": ""
    }
  ]
}