{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "215497",
      "product_res_number": "Z-2542-2025",
      "event_date_initiated": "2025-08-11",
      "event_date_posted": "2025-09-08",
      "recall_status": "Open, Classified",
      "res_event_number": "97398",
      "product_code": "CEK",
      "product_description": "Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.",
      "code_info": "Material Number: 11097543. Test Code: UCFP. UDI-DI: 00630414279206.  All lot numbers.",
      "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": "Jennifer Sacks\n443-793-7288",
      "reason_for_recall": "Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Siemens Healthcare Diagnostics notified consignees on about 08/11/2025 via letter. Customers were instructed to perform QC on each well, track additional reagent consumption (number of tests) to report to Siemens Healthineers for future reimbursement/credit, review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable, and retain this letter with your laboratory records and forward this letter to those who may have received this product.  Additionally, consignees were instructed to complete and return the Field Correction Effectiveness Check Form.",
      "product_quantity": "11,811 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Macedonia, Malaysia, Maldives, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, \nU.A.E., United¿Kingdom, Uruguay, Vatikancity, Vietnam, Zaire.",
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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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