{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "30511",
      "product_res_number": "Z-0278-04",
      "event_date_initiated": "2003-11-17",
      "event_date_posted": "2004-07-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-11-01",
      "res_event_number": "27780",
      "product_code": "LCD",
      "k_numbers": [
        "K840826",
        "K871645"
      ],
      "product_description": "Package Insert for TDx/TDxFLx and TDxFLx Gentamicin Reagents, REF 9512, item numbers 34-1074/R3 and 69-5120/R2; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064",
      "code_info": "Reagent List 9512-60,lots 06313Q100, 01368Q101, 95380Q100, 93579Q100, 90107Q100; and Reagent List 9512-85, lots 06312Q100, 02010Q100, 96606Q100, 95106Q100, 90108Q100 that contain insert item numbers 34-1074/R3 or 69-5120/R2",
      "firm_fei_number": "1415939",
      "recalling_firm": "Abbott Laboratories HPD/ADD/GPRD",
      "address_1": "100/200 Abbott Park Road",
      "city": "Abbott Park",
      "state": "IL",
      "postal_code": "60064",
      "additional_info_contact": "Abbott Customer Support\n877-422-2688",
      "reason_for_recall": "The package inserts contain incorrect values for the alternate unit (mol/L) Control Ranges",
      "root_cause_description": "Other",
      "action": "Field Correction recall by undated letter sent on 11/17/03 to all customers receiving the affected lots of reagents.  The accounts were informed of the incorrect values for the alternate unit (mol/L) Control Ranges listed in the package inserts of the reagent kits.  The letters contained a table listing the incorrect values and the correct values for each of the products, and the users were instructed to use the correct values listed in the table for the assays.  The letters also listed the package insert item numbers for the updated inserts being used in current reagent production.",
      "product_quantity": "9,010 kits",
      "distribution_pattern": "Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Venezuela, Colombia, Peru, Chile, Uruguay, Argentina, Brazil, Puerto Rico, San Salvador, Canada, Germany, England, Japan, Singapore, Hong Kong, India, Taiwan, Thailand, Malaysia, Pakistan, Korea, Australia, New Zealand, Honduras, Costa Rica, Aruba, Bahamas, Panama, St. Croix, Jamaica and Paraguay.",
      "openfda": {
        "k_number": [
          "K800150",
          "K020704",
          "K900703",
          "K895484",
          "K832056",
          "K871329",
          "K862260",
          "K874703",
          "K873855",
          "K953020",
          "K873854",
          "K913470",
          "K012978",
          "K042479",
          "K943982",
          "K811692",
          "K832445",
          "K102699",
          "K935376",
          "K903743",
          "K243500",
          "K831304",
          "K904305",
          "K060709",
          "K850060",
          "K831416",
          "K010984",
          "K962519",
          "K852672",
          "K893912",
          "K823387",
          "K940376",
          "K962819",
          "K860045",
          "K811744",
          "K012311",
          "K860868"
        ],
        "registration_number": [
          "2050012",
          "3004493545",
          "3012963943",
          "1319681",
          "1319808",
          "2050010",
          "3002809144",
          "3003561301",
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          "2250051",
          "2517506",
          "1219913",
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          "3002642396",
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          "3010825766",
          "3002806944",
          "3033967997",
          "2432235",
          "3000308930",
          "3006198300",
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        ],
        "fei_number": [
          "2050012",
          "3004493545",
          "3012963943",
          "2050010",
          "3002809144",
          "3003561301",
          "3005755244",
          "2250051",
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          "3002642396",
          "3005333358",
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          "3002806944",
          "3033967997",
          "3007019572",
          "2432235",
          "3000308930",
          "3006198300",
          "3010939897"
        ],
        "device_name": "Enzyme Immunoassay, Gentamicin",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3450",
        "device_class": "2"
      }
    }
  ]
}