{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "92709",
      "product_res_number": "Z-0612-2011",
      "event_date_initiated": "2010-06-24",
      "event_date_posted": "2010-12-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-08-08",
      "res_event_number": "56126",
      "product_code": "LKJ",
      "k_numbers": [
        "K954723"
      ],
      "product_description": "Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc.",
      "code_info": "Manufactured on 06/07/2010, lot number 24501097",
      "firm_fei_number": "2915274",
      "recalling_firm": "Bio-Rad Laboratories Inc",
      "address_1": "4000 Alfred Nobel Dr",
      "city": "Hercules",
      "state": "CA",
      "postal_code": "94547-1803",
      "additional_info_contact": "510-724-7000",
      "reason_for_recall": "Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect controls will cause run failure - patient results cannot be reported because controls will not pass..",
      "root_cause_description": "Labeling mix-ups",
      "action": "Bio-Rad issued Medical Device Recall Notification letters dated June 24, 2010 to consignees, identifying the affected products and requested that all affected product be disposed of in accordance with local procedures. Response forms are to be completed and returned to the firm. \nBio-Rad can be contacted for replacement product and about this recall at 510 741-6114.",
      "product_quantity": "37 units",
      "distribution_pattern": "Nationwide Distribution: including the states of California, Ohio, Massachusetts, and Missouri.\n\nProduct delivered to 11 consignees only in the US.",
      "openfda": {
        "k_number": [
          "K921132",
          "K954723",
          "K914454",
          "K893897",
          "K081104",
          "K831463",
          "K984470",
          "K874115",
          "K932302",
          "K042416",
          "K932679",
          "K894411",
          "K913342",
          "K993294",
          "K842484",
          "K984475",
          "K024223",
          "K920150",
          "K011244",
          "K914550",
          "K842563",
          "K984464",
          "K883949",
          "K893896",
          "K873249",
          "K021103",
          "K021257",
          "K024226",
          "K961815",
          "K885224",
          "K864668",
          "K030775",
          "K984473",
          "K082759",
          "K882740",
          "K041658",
          "K034013",
          "K954891",
          "K931255",
          "K210902",
          "K113610",
          "K862313",
          "K024218",
          "K954392",
          "K932876",
          "K912291",
          "K954700",
          "K024232",
          "K984478",
          "K883883"
        ],
        "registration_number": [
          "3004973408",
          "9680745",
          "8043792",
          "3032705",
          "3015376545",
          "2026994",
          "3003935253",
          "1318354",
          "2915274",
          "2242436",
          "3039353646",
          "9610566",
          "3007208259",
          "3003825930",
          "2918768",
          "1181055"
        ],
        "fei_number": [
          "3002807876",
          "3004973408",
          "3002701146",
          "3005774014",
          "3015376545",
          "2026994",
          "3003935253",
          "1318354",
          "2915274",
          "3002808269",
          "2242436",
          "3039353646",
          "3007208259",
          "3003825930",
          "2918768",
          "1181055"
        ],
        "device_name": "Antinuclear Antibody, Antigen, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5100",
        "device_class": "2"
      }
    }
  ]
}