{
  "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": "43314",
      "product_res_number": "Z-0327-06",
      "event_date_initiated": "2005-12-15",
      "event_date_posted": "2006-01-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-08-07",
      "res_event_number": "34238",
      "product_code": "LOM",
      "product_description": "Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324.  Firm on label:  Ortho-Clinical Diagnostics, 62 The Broadway, Amersham, Bucks, UK.  UPC *+H221680132412* .  Each kit contains: 1 x kit of reagents, and protocol card for HBsAg Confirmatory Kit.    According to the firm (but not on label), there are 60 neutralization reactions  per confirmatory kit.",
      "code_info": "Lot 5140, exp. 4/13/2006; Lot 5150, exp. 5/31/2006; and Lot 5160, exp. 7/3/2006",
      "firm_fei_number": "1000136573",
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "address_1": "100 Indigo Creek Dr",
      "city": "Rochester",
      "state": "NY",
      "postal_code": "14626-5101",
      "additional_info_contact": "Judy M. Strzepek\n908-218-8524",
      "reason_for_recall": "Increased background signal of the sample diluent in the affected Confirmatory Kits could cause some results to be classified as 'Not Confirmed'.",
      "root_cause_description": "Other",
      "action": "Letters sent overnight mail on 12/15/2005.  Customers instructed to discontinue use and discard remaining inventory.  In a separate Q&A sheet, Ortho recommends that previously reported results be reviewed.",
      "product_quantity": "436 kits",
      "distribution_pattern": "Nationwide distribution to end users (medical facilities, testing labs and public health agencies).  One J&J foreign affiliate in Puerto Rico with sub-distribution in the Caribbean.",
      "openfda": {
        "k_number": [
          "K260770"
        ],
        "pma_number": [
          "P080023",
          "P100032",
          "P060009",
          "P110029",
          "P790025",
          "P850044",
          "P030040",
          "P010050",
          "P180045",
          "P090028",
          "P210019",
          "P030049",
          "P840070",
          "P230015",
          "P050051",
          "P060003",
          "P210003",
          "P010051",
          "P870048",
          "P110041",
          "P180038",
          "P190017",
          "P100031",
          "P990038",
          "P830014",
          "P030026",
          "P100039",
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          "P110022",
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          "P990042",
          "P060034",
          "P060035",
          "P780016",
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          "P110031",
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          "P990012",
          "P110025",
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          "P030024",
          "P050048",
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          "P040004",
          "P990041",
          "P130015",
          "P180049",
          "P100001",
          "P010052",
          "P030029"
        ],
        "registration_number": [
          "2032682",
          "3012963943",
          "9612316",
          "3011989923",
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          "3002806944",
          "2432235",
          "3008576040",
          "3008344661",
          "3000308930",
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        ],
        "fei_number": [
          "3002808328",
          "3012963943",
          "3005670738",
          "3003952975",
          "3002807272",
          "3011989923",
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          "2432235",
          "3002808212",
          "3008576040",
          "3008344661",
          "3000308930",
          "3002701146"
        ],
        "device_name": "Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3172",
        "device_class": "2"
      }
    }
  ]
}