{
  "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,
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  "results": [
    {
      "cfres_id": "123731",
      "product_res_number": "Z-0550-2014",
      "event_date_initiated": "2013-11-08",
      "event_date_posted": "2013-12-19",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-09-18",
      "res_event_number": "66842",
      "product_code": "MRG",
      "k_numbers": [
        "K123983"
      ],
      "product_description": "FastPack Free T4 Immunoassay \r\nFastPack Vitamin D Immunoassay \r\nChemilunescence assay for the determination of Vitamin D\r\n\r\nThe FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer.",
      "code_info": "Testosterone. Catalog Number\t25000059. Lot Number\t1309062-2P.Exp Date: 7/9/2014",
      "firm_fei_number": "3003355251",
      "recalling_firm": "Qualigen Inc",
      "address_1": "2042 Corte del Nogal",
      "city": "Carlsbad",
      "state": "CA",
      "postal_code": "92011-1438",
      "additional_info_contact": "760-918-9165",
      "reason_for_recall": "Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.",
      "root_cause_description": "Process change control",
      "action": "Qualigen, Inc.,  notified customers of the recall by calling customers via telephone (with a telephone script) on 11/08/2013. The telephone (script) included the reason for recall, product description with codes, instructions and contact information. The customers were instructed to examine your inventory and discontinue use of the kits immediately. Qualigen will send you\r\nreplacement kits and provide you with a shipping label to return all of the defective kits including any that were partially used.\r\n\r\nFeel free to contact System Support at 760.579.6900 if you have any\r\nquestions or require assistance with returning your kits.",
      "product_quantity": "6",
      "distribution_pattern": "US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.",
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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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    }
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}