{
  "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,
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    }
  },
  "results": [
    {
      "cfres_id": "64469",
      "product_res_number": "Z-0065-2008",
      "event_date_initiated": "2007-09-05",
      "event_date_posted": "2007-10-31",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-11-15",
      "res_event_number": "44881",
      "product_code": "LOM",
      "pma_numbers": [
        "P060034"
      ],
      "product_description": "Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.",
      "code_info": "Lot 131BHH, Catalog # 26174",
      "firm_fei_number": "3008272466",
      "recalling_firm": "Bio-Rad Laboratories",
      "address_1": "6565 185th Ave NE",
      "city": "Redmond",
      "state": "WA",
      "postal_code": "98052-5039",
      "additional_info_contact": "Scott Dennis\n425-498-1741",
      "reason_for_recall": "Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL.",
      "root_cause_description": "Error in labeling",
      "action": "On 9/5/07 a letter titled \"IMPORTANT PRODUCT INFORMATION\" was sent to customers advising them of the issue and requesting customers make a note of the correction in their laboratory procedures and/or any existing copies of the package insert.  On 9/19/07 the firm sent a second letter (dated 9/18/07) via DHL titled \"URGENT PRODUCT CORRECTION\" and supplied a corrected package insert to replace the original insert sent.",
      "product_quantity": "46",
      "distribution_pattern": "Nationwide: Kits were distributed to 27 hospitals, clinics and testing labs throughout the US.",
      "openfda": {
        "k_number": [
          "K260770"
        ],
        "pma_number": [
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          "P840070",
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        "registration_number": [
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        "fei_number": [
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          "3008344661",
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          "3002806559",
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        ],
        "device_name": "Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3172",
        "device_class": "2"
      }
    }
  ]
}