{
  "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": "196750",
      "product_res_number": "Z-0342-2023",
      "event_date_initiated": "2022-10-19",
      "event_date_posted": "2022-12-06",
      "recall_status": "Open, Classified",
      "res_event_number": "91106",
      "product_code": "LFZ",
      "k_numbers": [
        "K982485"
      ],
      "product_description": "CMV IgM EIA, in vitro diagnostic.",
      "code_info": "Catalog Number: 25178\nUDI-DI Code: 00847865010733\nLot Numbers:\nB02022\nE10022\nG05022",
      "firm_fei_number": "3008272466",
      "recalling_firm": "Bio-Rad Laboratories, Inc.",
      "address_1": "6565 185th Ave Ne",
      "city": "Redmond",
      "state": "WA",
      "postal_code": "98052-5039",
      "additional_info_contact": "Anna Gralinska-Schram\n510-741-6643",
      "reason_for_recall": "Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On or about 10/19/2022, the firm sent an \"URGENT: Medical Device Recall\" letter via UPS overnight to customers to inform them, Bio-Rad has received complaints of an unusual increase in the positivity rate with the Bio-Rad CMV IgM EIA kits.\n\nCustomers are instructed to discontinue use and to dispose of any unused product of Batch NumbersB02022, E10022, and G05022 of the Bio-Rad CMV IgM EIA (Material No. 25178; GTIN/UDI 00847865010733) according to local waste management procedures. If you have further distributed or transferred the product to other Bio-Rad customers, or labs from your site, please be sure to notify those customers of this field action.\n\nFor any questions regarding this information, please contact Bio-Rad Laboratories\nTechnical Support at 1-800-2BIORAD (1-800-224-6723), option #2, and then option #3, or by\nemailing TechSupportUSSD-Redmond@Bio-Rad.com for further assistance.",
      "product_quantity": "180 kits",
      "distribution_pattern": "U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX\n\nO.U.S.: None",
      "openfda": {
        "device_name": "Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3175",
        "device_class": "2",
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}