{
  "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": "160563",
      "product_res_number": "Z-0393-2018",
      "event_date_initiated": "2017-07-18",
      "event_date_created": "2018-01-19",
      "recall_status": "Terminated",
      "event_date_terminated": "2018-07-09",
      "res_event_number": "78808",
      "product_code": "NSU",
      "product_description": "BD MAX\" UVE Specimen Collection Kit.\n Catalog Number(s): 443376 for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.",
      "code_info": "UDI: 30382904433766. All Lot numbers: All when used with catalog 443712, 443824 and 442970.",
      "firm_fei_number": "1119779",
      "recalling_firm": "Becton Dickinson & Co.",
      "address_1": "7 Loveton Cir",
      "city": "Sparks",
      "state": "MD",
      "postal_code": "21152-9212",
      "reason_for_recall": "BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reportable result may lead to repeat of the test and/or re-collection of a specimen.",
      "root_cause_description": "Use error",
      "action": "Customers were notified via UPS on 07/18/2017. The recall for BD MAX\" Vaginal Panel and BD MAX\" UVE Specimen Collection Kit was initiated on July 18, 2017 and expanded to include BD MAX\" CT/GC/TV on August 11, 2017. The recall expansion letter to customers was dated 08/14/2017.",
      "distribution_pattern": "US and OUS.",
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        "device_name": "Instrumentation For Clinical Multiplex Test Systems",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2570",
        "device_class": "2"
      }
    }
  ]
}