{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "30305",
      "product_res_number": "Z-0209-04",
      "event_date_initiated": "2003-11-05",
      "event_date_posted": "2003-12-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-07-20",
      "res_event_number": "27667",
      "product_code": "LOM",
      "product_description": "Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests and list 7C18-20, 4 x 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064",
      "code_info": "List 7C18-20, 4 x 100 test kit, lots 07779M300, exp 06/19/2004 and 95551M300, exp 01/26/2004; and list 7C18-25, 100 test kit, lot 07779M301, exp 06/19/2004",
      "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",
      "reason_for_recall": "Aspiration errors in the conjugate component due to microbial contamination of the conjugate.",
      "root_cause_description": "Other",
      "action": "Abbott affiliates in Canada, Germany, Australia, New Zealand, England and Japan were e-mailed copies of the recall letter on 11/5/03 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised of the aspiration errors in the conjugate component and were instructed to discontinue use and destroy any of the affected lots remaining.",
      "product_quantity": "2,244 kits",
      "distribution_pattern": "Canada, Japan, Australia, New Zealand, Germany and England",
      "openfda": {
        "k_number": [
          "K260770"
        ],
        "pma_number": [
          "P990044",
          "P840070",
          "P780016",
          "P180048",
          "P000014",
          "P100001",
          "P010053",
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          "P990042",
          "P090024",
          "P190034",
          "P110022",
          "P060035",
          "P990045",
          "P010051",
          "P100032",
          "P050049",
          "P030049",
          "P990043",
          "P190005",
          "P060034",
          "P060031",
          "P850044",
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          "P090028",
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          "P110031",
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          "P030029",
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        ],
        "registration_number": [
          "9610240",
          "9612316",
          "3008344661",
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        "fei_number": [
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          "3002806944",
          "3002701146",
          "3002806559",
          "1000306617"
        ],
        "device_name": "Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3172",
        "device_class": "2"
      }
    }
  ]
}