{
  "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": [
    {
      "cfres_id": "50573",
      "product_res_number": "Z-0706-2007",
      "event_date_initiated": "2004-09-29",
      "event_date_posted": "2007-04-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-05-01",
      "res_event_number": "37453",
      "product_code": "GIF",
      "k_numbers": [
        "K972354"
      ],
      "product_description": "CELL-DYN 3200 Diluent/Sheath Reagent,\nList Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA",
      "code_info": "Lot Numbers: 14465I2,  15597I2,  15598I2,  16752I2,  16753I2,  16754I2,  17943I2,  17946I2,  17947I2,  17949I2,  17950I2,  17952I2,  17953I2,  17954I2,  18107I2,  18108I2,  18109I2,  18110I2",
      "firm_fei_number": "2919069",
      "recalling_firm": "Abbott Laboratories",
      "address_1": "5440 Patrick Henry Dr",
      "city": "Santa Clara",
      "state": "CA",
      "postal_code": "95054-1113",
      "reason_for_recall": "Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 System and report  patient results that are unacceptable-out-of-range",
      "root_cause_description": "Other",
      "action": "On September 29, 2004, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be disposed.",
      "product_quantity": "27,411 units",
      "distribution_pattern": "Class II Recall-Worldwide Distribution- USA including states of IL, TX, GA, and PA. and countries of Argentina, Australia, Bahamas, Barbados, Brazil, British Virgin Islands, Colombia, Dominican Republic, Germany, Hong Kong, Japan, Korea, New Zealand, Puerto Rico, Singapore, Taiwan, Thailand, Trinidad & Tobago, Uruguay, and Venezuela.",
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        "device_name": "Diluent, Blood Cell",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.8200",
        "device_class": "1",
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