{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216573",
      "product_res_number": "Z-0489-2026",
      "event_date_initiated": "2025-09-18",
      "event_date_posted": "2025-11-12",
      "recall_status": "Open, Classified",
      "res_event_number": "97788",
      "product_code": "GKZ",
      "k_numbers": [
        "K220031",
        "K243283"
      ],
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      "firm_fei_number": "2919069",
      "recalling_firm": "Abbott Laboratories",
      "address_1": "4551 Great America Pkwy",
      "city": "Santa Clara",
      "state": "CA",
      "postal_code": "95054-1208",
      "additional_info_contact": "Suchin Song\n408-567-3313",
      "reason_for_recall": "Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.",
      "root_cause_description": "Software design",
      "action": "On September 18, 2025, Abbott Laboratories issued an \"Urgent Medical Device Recall\" Notification.  Abbott ask consignees to take the following actions:\n\n1. If IG/%IG is above your laboratory established reference range (e.g. greater than 2%), review the results per your laboratory procedures. A manual smear review may need to be performed to confirm the results.\n2. Complete and return the Customer Reply Form.\n3. If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter.\n4. Please retain this letter for your laboratory records.\n\nIf the problem persists, contact your Abbott representative or Abbott Technical Support \n(1-800-727-7846) for help to determine whether the inability to communicate is related to this issue.",
      "product_quantity": "833",
      "distribution_pattern": "Worldwide distribution: US (nationwide) to states of: AL, CA, CO, FL, IN, MN, NC, NY, OK and OUS (foreign) to countries of: ALBANIA, ARGENTINA,\tAUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT,\tFRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA,\tITALY, JAMAICA, JAPAN, JORDAN, KUWAIT,\tLEBANON, LITHUANIA, MALAYSIA, MALDIVES, MEXICO, NETHERLANDS,\tNORWAY, OMAN, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SERBIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE,UNITED KINGDOM,\tURUGUAY,  and VIETNAM.",
      "openfda": {
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