{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "199108",
      "product_res_number": "Z-1572-2023",
      "event_date_initiated": "2023-02-28",
      "event_date_posted": "2023-05-10",
      "recall_status": "Open, Classified",
      "res_event_number": "91889",
      "product_code": "MID",
      "k_numbers": [
        "K130528"
      ],
      "product_description": "BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack",
      "code_info": "Lot Code: 301538; UDI-DI: (00)847865000666",
      "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": "APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On February 28, 2023, Bio-Rad Laboratories issued an \"Urgent: Medical Device Recall\" letter to affected consignees. In addition, to informing consignees about the recall, they ask consignees to take the following actions:\n\nWe are requesting that customers perform quality control using the BioPlex APLS IgM\nControl Set (Catalog No. 663-2030, UDI GTIN 00847865000642) with each reagent pack ( single pack validation ) of BioPlex 2200 APLS IgM Reagent Pack, Lot No. 301538, until replacement product is provided. \n\nIf QC fails (controls below or above the acceptable range), please discontinue use of the reagent pack and dispose of it according to local waste management procedures. If the control values are within the acceptable range, the reagent pack may be used and patient results may be released. If you have distributed or transferred this product to any other Bio-Rad customers, or to any other laboratories from your site, please notify those customers of this field action.\n\nPlease complete the attached Customer Response Form and return it to your local Bio-Rad\nTechnical Support so they can assist you with obtaining replacement reagent packs as needed.",
      "product_quantity": "932 Reagent Packs",
      "distribution_pattern": "US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL, HI, IL, IN, KS, KY, LA, MI, MO, NC, ND, NE, NJ, NM, NY, OH, OK, PR,SC, TN, TX, UT, VT.",
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          "K955449",
          "K021398",
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        ],
        "device_name": "System, Test, Anticardiolipin Immunological",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5660",
        "device_class": "2",
        "registration_number": [
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