{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "92515",
      "product_res_number": "Z-0540-2011",
      "event_date_initiated": "2010-03-01",
      "event_date_posted": "2010-12-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-01-05",
      "res_event_number": "56047",
      "product_code": "LKJ",
      "k_numbers": [
        "K954723"
      ],
      "product_description": "Autoimmune EIA ANA Screening Test Kit, 576 Tests,\nModel/Catalog Number: 576AN manufactured by Bio-Rad, Hercules, CA.",
      "code_info": "Lot Numbers:  24591525,  24591572,  24592100,  24592396,  24500034",
      "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": "The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.",
      "root_cause_description": "Other",
      "action": "Bio-Rad issued an Urgent Medical Device Recall Notification letter dated March 1, 2010 to customers describing the issue and actions to be taken. Responses will be tracked via response forms. The letter instructed customers that affected products should be identified, quarantined, and discarded, or reworked with shorter expiration dates until newer lots are available.\nBio-Rad can be contacted at 510-724-7000 concerning this recall.",
      "distribution_pattern": "Worldwide Distribution: Throughout the US, and to the countries of: Australia, Canada, France, Hong Kong, India, Italy, Japan, New Zealand, Panama, Singapore, South Korea and the UK.",
      "openfda": {
        "k_number": [
          "K873249",
          "K034013",
          "K954392",
          "K862313",
          "K913342",
          "K954891",
          "K030775",
          "K984473",
          "K842563",
          "K874115",
          "K021103",
          "K932679",
          "K082759",
          "K932876",
          "K883949",
          "K024223",
          "K993294",
          "K882740",
          "K024226",
          "K984464",
          "K864668",
          "K914454",
          "K894411",
          "K984478",
          "K831463",
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          "K842484",
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          "K113610",
          "K954723",
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          "K893896",
          "K021257",
          "K984475",
          "K931255",
          "K081104",
          "K914550"
        ],
        "registration_number": [
          "2915274",
          "3004973408",
          "8043792",
          "9610566",
          "3003825930",
          "2242436",
          "2026994",
          "2918768",
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          "3007208259",
          "3015376545",
          "1318354",
          "1181055",
          "3039353646",
          "3032705",
          "9680745"
        ],
        "fei_number": [
          "2915274",
          "3004973408",
          "3002808269",
          "3003825930",
          "2242436",
          "2026994",
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          "3002701146",
          "1318354",
          "1181055",
          "3039353646",
          "3002807876",
          "3003935253"
        ],
        "device_name": "Antinuclear Antibody, Antigen, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5100",
        "device_class": "2"
      }
    }
  ]
}