{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "193174",
      "product_res_number": "Z-1096-2022",
      "event_date_initiated": "2022-04-14",
      "event_date_created": "2022-05-16",
      "recall_status": "Open, Classified",
      "res_event_number": "90026",
      "product_code": "LIP",
      "product_description": "BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack",
      "code_info": "Model/Catalog Number: 12000670\nUDI-DI (GTIN) Code: 03610520992715\nLot Number: 301388",
      "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": "Tina Cuccia\n425-498-1758",
      "reason_for_recall": "Performance concerns for the CMV IgM analyte.  Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 04/14/2022, Bio-Rad Laboratories sent an \"URGENT: Medical Device Recall\" letter via FedEx to customers informing them that Bio-Rad has identified a performance concern for the CMV IgM analyte in the BioPlex 2200 ToRC IgM kit lot 301388. The CMV IgM analyte has demonstrated variable elevated background depending on the handling of the reagent pack. Agitation of the conjugate within the reagent pack has demonstrated a potential for both false negative and false positive results for the CMV IgM assay. QC failures may prevent the release of incorrect results; however, QC may not detect all occurrences of the issue.\n\nCustomers are instructed to immediately discontinue use and to dispose of any unused product of Lot No. 301388.\n\nIf the affected lot has been further distributed or transferred the product to other Bio-Rad customers, or labs, these customer/labs should be notified of this field action/recall.\n\nFor questions or further assistance, contact local Bio-Rad Technical Support.",
      "product_quantity": "348 units",
      "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA, FL, HI, IA, IL, MI, MN, NE, NY, TN, TX, and WA. The countries of Czech Republic, France, Germany, and Italy.",
      "openfda": {
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        "registration_number": [
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        "fei_number": [
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        ],
        "device_name": "Enzyme Linked Immunoabsorption Assay, Treponema Pallidum",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3830",
        "device_class": "2"
      }
    }
  ]
}