{
  "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": "Ongoing",
      "city": "Lugano",
      "state": "N/A",
      "country": "Switzerland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85469",
      "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": "Letter",
      "distribution_pattern": "US Nationwide distribution including in the states of IL, NY.",
      "recall_number": "Z-2198-2020",
      "product_description": "FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.",
      "product_quantity": "71 systems",
      "reason_for_recall": "Potential for discrepant patient results due to a potential for the primary sample tube to be diluted.  In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of the hydraulic circuit of the Aliquoter Module.",
      "recall_initiation_date": "20200407",
      "center_classification_date": "20200601",
      "report_date": "20200610",
      "code_info": "Serial Numbers:  FLX.008  FLX.0105  FLX.0106  FLX.0107  FLX.0113  FLX.0114  FLX.0115  FLX.0116  FLX.0118  FLX.0119  FLX.012  FLX.0121  FLX.0124  FLX.0125  FLX.0126  FLX.0127  FLX.0128  FLX.0129  FLX.0131  FLX.0135  FLX.0136  FLX.0138  FLX.014  FLX.0140  FLX.0141  FLX.0143  FLX.015  FLX.0152  FLX.0155  FLX.0158  FLX.0161  FLX.0164  FLX.017  FLX.018  FLX.0196  FLX.020  FLX.021  FLX.022  FLX.023  FLX.027  FLX.029  FLX.030  FLX.031  FLX.032  FLX.033  FLX.037  FLX.038  FLX.039  FLX.043  FLX.044  FLX.046  FLX.047  FLX.050  FLX.051  FLX.052  FLX.056  FLX.060  FLX.064  FLX.071  FLX.072  FLX.074  FLX.075  FLX.076  FLX.077  FLX.080  FLX.082  FLX.083  FLX.093  FLX.101  FLX.102  TSH.003"
    }
  ]
}