{
  "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-0433-2021",
      "product_description": "Accelerator a3600 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": "136",
      "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:   ACP.048  ACP.142  ACP.194  ACP.113  ACP.104  ACP.244  ACP.252  ACP.253  ACP.268  ACP.290  ACP.363  ACP.181  ACP.009  ACP.015  ACP.027  ACP.042  ACP.092  ACP.432  ACP.303  ACP.004  ACP.011  ACP.028  ACP.093  ACP.163  ACP.226  ACP.275  ACP.267  ACP.276  ACP.329  ACP.033  ACP.012  ACP.235  ACP.064  ACP.164  ACP.209  ACP.217  ACP.263  ACP.295  ACP.297  ACP.323  ACP.396  ACP.410  ACP.115  ACP.214  ACP.331  ACP.243  ACP.259  ACP.085  ACP.141  ACP.237  ACP.172  ACP.218  ACP.257  ACP.280  ACP.336  ACP.364  ACP.298  ACP.337  ACP.066  ACP.088  ACP.123  ACP.248  ACP.182  ACP.442  ACP.291  ACP.026  ACP.047  ACP.171  ACP.265  ACP.426  ACP.018  ACP.286  ACP.102  ACP.063  ACP.076  ACP.230  ACP.233  ACP.258  ACP.334  ACP.360  ACP.378  ACP.391  ACP.437  ACP.250  ACP.314  ACP.439  ACP.440  ACP.073  ACP.185  ACP.186  ACP.146  ACP.205  ACP.371  ACP.394  ACP.270  ACP.272  ACP.284  ACP.318  ACP.002  ACP.019  ACP.034  ACP.045  ACP.050  ACP.052  ACP.059  ACP.061  ACP.069  ACP.070  ACP.071  ACP.101  ACP.119  ACP.120  ACP.131  ACP.229  ACP.232  ACP.236  ACP.242  ACP.289  ACP.294  ACP.299  ACP.304  ACP.332  ACP.321  ACP.342  ACP.344  ACP.359  ACP.361  ACP.372  ACP.375  ACP.424  ACP.428  ACP.431  ACP.436  ACP.451  ACP.454  ACP.278",
      "more_code_info": ""
    }
  ]
}