{
  "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": "2026-07-08",
    "results": {
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  "results": [
    {
      "status": "Ongoing",
      "city": "Lugano",
      "state": "",
      "country": "Switzerland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97565",
      "recalling_firm": "Inpeco S.A.",
      "address_1": "Via San Gottardo 10",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US distribution to CA & NY.",
      "recall_number": "Z-0107-2026",
      "product_description": "FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic",
      "product_quantity": "1 unit",
      "reason_for_recall": "The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.",
      "recall_initiation_date": "20250903",
      "center_classification_date": "20251009",
      "report_date": "20251015",
      "code_info": "PN: FLX-056-40; UDI: 07640172344002: Serial No. FXX.0015.",
      "more_code_info": ""
    }
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}