{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lugano",
      "state": "",
      "country": "Switzerland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86581",
      "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": "Letter",
      "distribution_pattern": "Global Distribution including: USA and countries of: Algeria, Australia, Azerbaijan, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Egypt, Finland, France, Germany, Indonesia, Israel, Italy, Libano, Mexico, Netherlands, Philippines, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, and United Arab Emirates.",
      "recall_number": "Z-0432-2021",
      "product_description": "FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212)    The FlexLab (aka Accelerator a3600 and Aptio 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 systems consolidate multiple Analytical instruments into a unified workstation.",
      "product_quantity": "93",
      "reason_for_recall": "When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is  flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 recommends that the operator manages these Secondary Sample Tubes according to Laboratory Practice, but it does not clarify that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module this may lead to reporting of erroneous results if the diluted sample is used for testing.",
      "recall_initiation_date": "20200714",
      "center_classification_date": "20201106",
      "termination_date": "20231228",
      "report_date": "20201118",
      "code_info": "The impacted modules are the Aliquoter Modules (lnpeco Part Number FLX-212) with the firmware versions listed below or higher:  - AQMb_3-3-0.H86  - AQMa_3-1-1-8.H86 and AQMb_3-1-1-8.H86  - xAQMb_1-1-0.elf;    System Serial Numbers:   FLX.008  FLX.0118  FLX.064  FLX.101  FLX.0116  FLX.0125  FLX.080  FLX.0206  FLX.0161  FLX.0152  FLX.012  FLX.0121  FLX.0155  FLX.033  FLX.047  FLX.0127  FLX.0128  FLX.0129  FLX.074  FLX.076  FLX.0113  FLX.0138  FLX.014  FLX.015  FLX.0164  FLX.051  FLX.0106  FLX.0158  FLX.0196  FLX.072  FLX.0107  FLX.0189  FLX.0126  FLX.0165  FLX.0135  FLX.017  FLX.0114  FLX.022  FLX.0119  FLX.0105  FLX.029  FLX.0115  FLX.031  FLX.032  FLX.0141  FLX.037  FLX.020  FLX.039  FLX.043  FLX.102  FLX.046  FLX.0143  FLX.050  FLX.0124  FLX.0131  FLX.056  FLX.060  FLX.0136  FLX.0140  FLX.018  FLX.021  FLX.023  FLX.030  FLX.044  FLX.052  FLX.082  FLX.083  FLX.093  FLX.071  FLX.077  TSH.003  FLX.0146  FLX.027  FLX.038  FLX.075  FLX.0160  FLX.0153  FLX.0154  FLX.0157  FLX.0166  FLX.0167  FLX.0170  FLX.0174  FLX.0179  FLX.0180  FLX.0182  FLX.0194  FLX.0183  FLX.0048  FLX.0049  FLX.0109  FLX.0145  FLX.0148",
      "more_code_info": ""
    }
  ]
}