{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "218477",
      "product_res_number": "Z-1484-2026",
      "event_date_initiated": "2026-01-20",
      "event_date_posted": "2026-03-02",
      "recall_status": "Open, Classified",
      "res_event_number": "98370",
      "product_code": "JIR",
      "product_description": "Atellica CH Urine Albumin (UAlb). Material Number: 11537225",
      "code_info": "Material Number: 11537225. \nUDI-DI: 00630414611099. \nLot Numbers: 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": "914-631-8000",
      "reason_for_recall": "Falsely depressed UAlb patient\nresults may occur. Affected samples with any urine albumin concentration above the UAlb\nmeasuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Siemens Healthineers notified consignees on about 01/20/2026 via mailed FedEx letter titled Urgent Medical Device Correction. Consignees were informed that as temporary mitigation, for any sample with a UAlb result above 5.0 mg/dL (50 mg/L), reanalyze the sample with a x10 dilution. If the diluted result is consistent with the initial result, either result may be reported. If the diluted result is inconsistent with the initial result, the diluted result should be reported. If you prefer to automate this dilution, please refer to your internal laboratory procedures.\n\nConsignees were instructed to review the notification with their Medical Director to determine the appropriate course of action, including evaluation of any previously generated results, if applicable, and complete and return the provided Field Correction Effectiveness Check Form. A follow-up communication will be provided when  Customer Actions  are no longer required.",
      "product_quantity": "4,885 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Curacao,¿St¿Eus, Czech¿Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Korea, Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United¿Kingdom.",
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        "device_name": "Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1645",
        "device_class": "1"
      }
    }
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}