{
  "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": "73408",
      "product_res_number": "Z-0908-2010",
      "event_date_initiated": "2008-08-20",
      "event_date_posted": "2010-03-02",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-04-08",
      "res_event_number": "49449",
      "product_code": "LFX",
      "k_numbers": [
        "K961053"
      ],
      "product_description": "Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1 Low Positive Control, 1 Substrate, 1 Stop Reagent.  Labeled: Distributed by: Bio-Rad Laboratories-Redmond, WA 98052\n\nFor the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment to the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age.",
      "code_info": "Lot  F1108",
      "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": "425-498-1709",
      "reason_for_recall": "Elevated optical density (OD) values with the kit Negative Control.",
      "root_cause_description": "Employee error",
      "action": "An \"Urgent Product Correction\" letter dated August 26, 2008 was sent via overnight carrier to all customers.  The letter described the affected product, problem, and action to be taken by customer.  The customers are to review their current inventory of the product for any remaining kits of the specified lot number. The customer is to complete the form and fax to the Technical Support department if replacement kits were needed.  The remaining kits will be replaced once the form is completed and faxed.\n\nIf you have any questions, please contact Technical Support at 1-800-224-6723, options 2 then 4.",
      "product_quantity": "82 kits",
      "distribution_pattern": "Nationwide distribution: NE, NY, FL, GA, MA, OR, WI, MN, MI, MS, NC, CA, MD, MO, IA, DC",
      "openfda": {
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        "fei_number": [
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        ],
        "device_name": "Enzyme Linked Immunoabsorbent Assay, Rubella",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3510",
        "device_class": "2"
      }
    }
  ]
}