{
  "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-2975-2020",
      "product_description": "Aptio Automation systems 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 Clinical Chemistry Test Systems - 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": "10 US and  22 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:  AP2.0111  AP2.0137  AP2.0190  AP2.0191  AP2.0290  AP2.0296  AP2.0321  AP2.0322  AP2.0349  AP2.0385  AP2.0398      OUS:  AP2.0111  AP2.0113  AP2.0143  AP2.0170  AP2.0225  AP2.0242  AP2.0250  AP2.0259  AP2.0265  AP2.0270  AP2.0285  AP2.0295  AP2.0316  AP2.0350  AP2.0382  AP2.0388  AP2.0389  AP2.0390  AP2.0392  AP2.0448  APT.0058  APT.0065"
    }
  ]
}