{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "189522",
      "product_res_number": "Z-0180-2022",
      "event_date_initiated": "2021-09-20",
      "event_date_created": "2021-10-28",
      "recall_status": "Open, Classified",
      "res_event_number": "88784",
      "product_code": "CEK",
      "product_description": "Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543",
      "code_info": "All lots impacted",
      "firm_fei_number": "2432235",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "511 Benedict Ave",
      "city": "Tarrytown",
      "state": "NY",
      "postal_code": "10591-5005",
      "additional_info_contact": "914-631-8000",
      "reason_for_recall": "The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.",
      "root_cause_description": "Software design",
      "action": "On September 20, 2021, the firm distributed Urgent Medical Device Correction letters to impacted customers. Atellica customers were informed that the resolution of the issue will be implemented in SW v1.25.1. ADVIA customers were informed that the resolution of the issue will be implemented in AP Tool v1.11 and TDef v.1.07. These updates will be available soon. In the interim, customers were provided additional instructions to work around the issue until the update is available.\n\nIf you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.",
      "product_quantity": "1402 (US); 2941 (OUS)",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution.",
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        "device_name": "Biuret (Colorimetric), Total Protein",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1635",
        "device_class": "2"
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}