{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lugano",
      "state": "N/A",
      "country": "Switzerland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86263",
      "recalling_firm": "Inpeco S.A.",
      "address_1": "Via San Gottardo 10",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of AK, FL, IA, LA, MA, MS, MT, NC, OH, TX, VA and the countries of AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, NETHERLANDS.  NORWAY  SAUDI ARABIA  SOUTH KOREA  SWEDEN  UNITED ARAB EMIRATES",
      "recall_number": "Z-2973-2020",
      "product_description": "FlexLab (FLX)  with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and   Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that perform a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.",
      "product_quantity": "2 US and 6 OUS",
      "reason_for_recall": "Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the  potential to mis-associate sample IDs leading to incorrect results or delayed results",
      "recall_initiation_date": "20200807",
      "center_classification_date": "20200916",
      "termination_date": "20211202",
      "report_date": "20200923",
      "code_info": "Serial Numbers:  US:  FLX.0133  FLX.0181    OUS:  FLX.0048  FLX.0049  FLX.0121  FLX.0155  FLX.0160  FLX.0200"
    }
  ]
}