{
  "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": "2026-08-13",
    "results": {
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  "results": [
    {
      "cfres_id": "189788",
      "product_res_number": "Z-0193-2022",
      "event_date_initiated": "2021-10-06",
      "event_date_created": "2021-11-02",
      "recall_status": "Open, Classified",
      "res_event_number": "88865",
      "product_code": "CDT",
      "k_numbers": [
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      "product_description": "Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038",
      "code_info": "UDI 00630414596754",
      "firm_fei_number": "2517506",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 Gbc Dr",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19702-2466",
      "additional_info_contact": "800-441-9250",
      "reason_for_recall": "The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and clinical decisions.",
      "root_cause_description": "Software design",
      "action": "On October 6, 2021, the firm notified affected customers via an \"Urgent Medical Device Correction\" letter. \n\nCustomers were informed of the product issue and provided instructions on actions to be taken by laboratories, which prevent the issue from happening.\n\nIf you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.\n\nA new version of the Firmware for the Aptio Automation Interface Module to the ADVIA Centaur XP/XPT will correct the issue. Your service provider will contact you to schedule the firmware upgrade.",
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