{
  "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-0434-2021",
      "product_description": "Aptio 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": "104",
      "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:   AP2.0005  AP2.0008  AP2.0010  AP2.0014  AP2.0017  AP2.0018  AP2.0022  AP2.0023  AP2.0026  AP2.0027  AP2.0033  AP2.0036  AP2.0039  AP2.0043  AP2.0045  AP2.0056  AP2.0060  AP2.0065  AP2.0069  AP2.0070  AP2.0071  AP2.0076  AP2.0078  AP2.0081  AP2.0087  AP2.0089  AP2.0102  AP2.0104  AP2.0105  AP2.0110  AP2.0111  AP2.0113  AP2.0120  AP2.0127  AP2.0137  AP2.0139  AP2.0146  AP2.0147  AP2.0149  AP2.0151  AP2.0155  AP2.0165  AP2.0170  AP2.0172  AP2.0184  AP2.0189  AP2.0201  AP2.0202  AP2.0203  AP2.0209  AP2.0211  AP2.0213  AP2.0217  AP2.0223  APT.0009  APT.0014  APT.0058  APT.0065  APT.0093  APT.0091  APT.0125  AP2.0225  AP2.0230  AP2.0232  AP2.0233  AP2.0240  AP2.0242  AP2.0253  AP2.0266  AP2.0265  AP2.0268  AP2.0269  AP2.0238  AP2.0248  AP2.0274  AP2.0283  AP2.0289  AP2.0285  AP2.0295  AP2.0296  AP2.0303  AP2.0308  AP2.0332  AP2.0350  AP2.0353  AP2.0352  AP2.0354  AP2.0346  AP2.0361  AP2.0366  AP2.0388  AP2.0393  AP2.0402  AP2.0403  AP2.0404  AP2.0405  AP2.0389  AP2.0390  AP2.0400  AP2.0401  AP2.0421  AP2.0420  AP2.0427  AP2.0412",
      "more_code_info": ""
    }
  ]
}