{
  "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": "2026-08-22",
    "results": {
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  "results": [
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      "cfres_id": "91152",
      "product_res_number": "Z-0588-2011",
      "event_date_initiated": "2010-03-10",
      "event_date_posted": "2010-12-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-08-04",
      "res_event_number": "55571",
      "product_code": "CHI",
      "k_numbers": [
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      "product_description": "Dimension LIP Flex Reagent Cartridge, Catalog# DF55A",
      "code_info": "Lot Number: DE0320, FC0306, GB0342, EA0334, FB0278, DA0293, GB0286, FA0355, EA0362, EB0362.",
      "firm_fei_number": "2517506",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 GBC Drive, Mailstop 514 500 GBC Drive Mailstop 514",
      "address_2": "PO BOX 6101",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19714-6101",
      "additional_info_contact": "Siemens Technical Solutions Center\n800-441-9250",
      "reason_for_recall": "Open Well instability: After calibration, QC shifts high (out of range) after the Flex Well is hydrated. Shifts of up to 20% have been observed in both QC and patient samplesas soon as two hours post hydration.",
      "root_cause_description": "Other",
      "action": "Recalling firm issued \"Urgent Field Safety Notice\", dated March 2010, informing users of the problem and to transition to the revised Lipasae method.",
      "product_quantity": "21171",
      "distribution_pattern": "Nationwide Distribution throughout the US.",
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        "device_name": "Lipase-Esterase, Enzymatic, Photometric, Lipase",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1465",
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