{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "86768",
      "product_res_number": "Z-0899-2010",
      "event_date_initiated": "2009-11-16",
      "event_date_posted": "2010-03-02",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-06-06",
      "res_event_number": "53872",
      "product_code": "JIY",
      "k_numbers": [
        "K864882"
      ],
      "product_description": "Pointe Scientific Iron/TIBC Reagent Set, for the quantitative determination of serum iron and iron binding capacity, Pointe Scientific, Inc, Canton, MI, Catalog #s:  I7504-60, I7504-400, I7504-SAM, 10-I7504-60. \n\nClinical chemistry reagent for the quantitative determination of iron in serum.",
      "code_info": "All lot numbers containing the numbers 735401 or 816501.",
      "firm_fei_number": "1827821",
      "recalling_firm": "Pointe Scientific, Inc.",
      "address_1": "5449 Research Dr",
      "city": "Canton",
      "state": "MI",
      "postal_code": "48188",
      "additional_info_contact": "734-487-8300",
      "reason_for_recall": "Turbidity formation could occur, resulting in invalid test results being reported out.",
      "root_cause_description": "Device Design",
      "action": "Consignees were notified by recall letter dated 11/16/09 and instructed to discard any remaining product.  \n\nPlease call 1-800-757-5313 if you have questions.",
      "product_quantity": "417 sets",
      "distribution_pattern": "Nationwide, Australia, Austria, Bolivia, Canada, Cyprus, Egypt, Ghana, Greece, Guyana, India, Indonesia, Israel, Jordan, Kenya, Korea, Lebanon, Macedonia, Malaysia, Mexico, Nicaragua, Nigeria, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Trinidad,  Turkey, Ukraine and Venezuela.",
      "openfda": {
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          "K874263",
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          "K935287",
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          "K051115",
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          "K861652",
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        ],
        "device_name": "Photometric Method, Iron (Non-Heme)",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1410",
        "device_class": "1",
        "registration_number": [
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}