{
  "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": "2026-10-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "66385",
      "product_res_number": "Z-1159-2008",
      "event_date_initiated": "2007-11-13",
      "event_date_posted": "2008-06-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-05-23",
      "res_event_number": "45875",
      "product_code": "LKJ",
      "k_numbers": [
        "K043341"
      ],
      "product_description": "BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) the 5,000 tests - Catalog No. 665-1155 - manufactured by Bio-Rad Laboratories in Redmond, WA.  The product is used as an aid in the diagnosis of systemic autoimmune diseases.",
      "code_info": "Eleven (11) Lots, as follows: Lot Numbers: 931396 Exp. 9/30/06; 935424 Exp. 3/31/07; 941886 Exp. 3/31/07; 935682 Exp. 4/30/07; 937351 Exp. 6/30/07; 941343 Exp. 3/31/08; 941428 Exp. 4/30/08; 945246 Exp. 9/30/08; 945875 Exp. 12/31/08; 945248 Exp. 10/31/08 and 945875 Exp. 12/31/08   ****",
      "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 J. Dennis\n425-498-1709",
      "reason_for_recall": "False negative results due to reagent packs exhibiting low signal.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On 11/13/2007, the firm faxed Voluntary Field Correction Letters (which are dated 11/9/2007) to its consignees and also contacted them via telephone. The Voluntary Field Correction Letters: a) informed them of the potential for false negative results; b) recommended that they perform QC testing daily with each reagent pack; c) provided a new insert for the Instructions for Use; and d)  provided a Response Sheet for each consignee to complete and return to the firm.",
      "product_quantity": "8,804 kits",
      "distribution_pattern": "Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.",
      "openfda": {
        "k_number": [
          "K894411",
          "K034013",
          "K030775",
          "K021257",
          "K042416",
          "K024218",
          "K984470",
          "K954392",
          "K021103",
          "K932302",
          "K914550",
          "K954891",
          "K984473",
          "K882740",
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          "K831463",
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          "K081104",
          "K862313",
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          "K984464",
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          "K961815",
          "K011244",
          "K984478",
          "K082759",
          "K932876",
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          "K113610",
          "K912291",
          "K913342",
          "K864668",
          "K024223",
          "K921132",
          "K920150",
          "K883883",
          "K893896"
        ],
        "device_name": "Antinuclear Antibody, Antigen, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5100",
        "device_class": "2",
        "registration_number": [
          "9610566",
          "2242436",
          "8043792",
          "2026994",
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          "3002701146"
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      }
    }
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}