{
  "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": "65277",
      "product_res_number": "Z-0256-2008",
      "event_date_initiated": "2007-09-25",
      "event_date_posted": "2007-11-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-04-16",
      "res_event_number": "45332",
      "product_code": "LIP",
      "k_numbers": [
        "K063866"
      ],
      "product_description": "BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the Syphilis IgG Assay Protocol File LAPF CD",
      "code_info": "Cat. No. 665-1460A containing APF CD SW2_v1.",
      "firm_fei_number": "2915274",
      "recalling_firm": "Bio-Rad Labroatories Inc.",
      "address_1": "4000 Alfred Noble Dr.",
      "city": "Hercules",
      "state": "CA",
      "postal_code": "94547",
      "additional_info_contact": "510-741-7000",
      "reason_for_recall": "Mislabeling: Reporting terminology in the Syphilis IgG APF CD is not consistent with the distributed  Instructions for Use. (Non-Reactive and Reactive rather than Negative and Positive)",
      "root_cause_description": "Labeling Change Control",
      "action": "The recalling firm notified consignees by phone call on 9/25/2007,  followed up with a  fax notification. The firm plans to monitor the consignees that do not respond by tracking on a spreadsheet and following up with another phone call.  Consignees are instructed to destroy the APF CD which will be replaced at a later date.",
      "product_quantity": "36",
      "distribution_pattern": "Nationwide",
      "openfda": {
        "k_number": [
          "K014233",
          "K241534",
          "K153730",
          "K881425",
          "K091361",
          "K820934",
          "K961317",
          "K850329",
          "K904524",
          "K883938",
          "K160910",
          "K895965",
          "K093837",
          "K061247",
          "K960493",
          "K992552",
          "K241427",
          "K932453",
          "K895964",
          "K102283",
          "K883939",
          "K910487",
          "K120439",
          "K001552",
          "K170413",
          "K871548",
          "K050590",
          "K102400",
          "K063866",
          "K112343",
          "K001525",
          "K211302",
          "K900654",
          "K153145",
          "K053570"
        ],
        "registration_number": [
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          "3011989923",
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          "1318354",
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          "3032705"
        ],
        "fei_number": [
          "2245285",
          "3005670738",
          "3011989923",
          "3003992026",
          "2431980",
          "3000254998",
          "1641328",
          "2915274",
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          "3002808212",
          "2432235",
          "1318354",
          "2122870",
          "3022178699",
          "3002800697"
        ],
        "device_name": "Enzyme Linked Immunoabsorption Assay, Treponema Pallidum",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3830",
        "device_class": "2"
      }
    }
  ]
}