{
  "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,
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  "results": [
    {
      "cfres_id": "167482",
      "product_res_number": "Z-0410-2019",
      "event_date_initiated": "2018-09-11",
      "event_date_created": "2018-11-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-09-01",
      "res_event_number": "81121",
      "product_code": "MRG",
      "k_numbers": [
        "K123364"
      ],
      "product_description": "R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971",
      "code_info": "Manufacturing Lot # 182801",
      "firm_fei_number": "2182501",
      "recalling_firm": "R & D Systems, Inc.",
      "address_1": "614 McKinley Pl NE",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55413-2610",
      "additional_info_contact": "Rachel Somsen\n612-851-4846",
      "reason_for_recall": "The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "The firm contacted the consignees (end users) by telephone on 09/11/2018 to alert them of the issue.  The firm followed with an email on 09/21/2018 restating the issue and offering to replace any unused kits.",
      "product_quantity": "8 kits",
      "distribution_pattern": "IA and CO",
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        "device_name": "System, Test, Vitamin D",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1825",
        "device_class": "2"
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}