{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "167544",
      "product_res_number": "Z-0491-2019",
      "event_date_initiated": "2018-08-30",
      "event_date_created": "2018-11-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-10-21",
      "res_event_number": "81148",
      "product_code": "JTW",
      "k_numbers": [
        "K790366"
      ],
      "product_description": "BD Vacutainer Urine Collection Cups, Cat. No. 364941",
      "code_info": "All lots within expiry",
      "firm_fei_number": "2243072",
      "recalling_firm": "Becton Dickinson & Company",
      "address_1": "1 Becton Dr",
      "city": "Franklin Lakes",
      "state": "NJ",
      "postal_code": "07417-1815",
      "additional_info_contact": "Customer service\n410-316-4050",
      "reason_for_recall": "BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice (GCP) by using microscopy to confirm an elevated RBC Count in a Urine sample as per CLSI GP16-3A. 29(4) and CAP Checklist on Urinalysis. Product will continue to ship to not impact critical patient care.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On August 30, 2018, BD notified Sysmex via an emailed Urgent Medical Device Product Safety Alert letter. Sysmex was informed that BD had confirmed the product issue with BD Vacutainer Urine Collection Cups were used with Sysmex UF Series Analyzers.\n\nSysmex was instructed to take the following actions:\n\n- Notify Sysmex customers of the potential for elevation of RBC counts\n- Complete the customer Resopnse form and email it to BD at Gail_Griffiths@bd.com to confirm receipt of the Safety Alert.\n\nProduct will continue to ship so as to not impact critical patient care.\n\nBD recommends following Good Clinical Practice (GCP) by performing microscopy to confirm an elevated RBC Count in a urine sample as per CLSI GP16-3A.29(4) and CAP Checklist on Urinalysis.",
      "product_quantity": "Total: 29,982,150 BD cups (US); 97,800,900 BD cups (OUS)",
      "distribution_pattern": "Illinois",
      "openfda": {
        "k_number": [
          "K843173",
          "K830250",
          "K872326",
          "K022874",
          "K872325",
          "K993161",
          "K772206",
          "K121039",
          "K831579",
          "K770683",
          "K843359",
          "K013819",
          "K803298",
          "K790366",
          "K772207",
          "K760458",
          "K811284",
          "K791924",
          "K780440",
          "K771058",
          "K772208",
          "K823443",
          "K934894",
          "K791953",
          "K772210",
          "K840991",
          "K840719",
          "K811283",
          "K840968",
          "K760054",
          "K840990",
          "K882580",
          "K802563",
          "K895187",
          "K802023",
          "K843341",
          "K983244",
          "K770957",
          "K904773",
          "K772209",
          "K961148",
          "K061301",
          "K772205"
        ],
        "registration_number": [
          "3010132111",
          "2243072",
          "3010407203",
          "1216735",
          "3036773433",
          "9610126",
          "3013517171",
          "1924669",
          "1220477",
          "2649614",
          "3002806470",
          "3010155648",
          "3001124136",
          "8021914",
          "1917413",
          "9681465",
          "3011088743",
          "1420054",
          "3016587486",
          "3012494290",
          "3015441043",
          "3011689956",
          "3013557562",
          "3043226252",
          "3002444944"
        ],
        "fei_number": [
          "3010132111",
          "3002807113",
          "2243072",
          "3010407203",
          "1216735",
          "3002806332",
          "3036773433",
          "3013517171",
          "1924669",
          "1220477",
          "2649614",
          "3002806470",
          "3010155648",
          "3001124136",
          "1917413",
          "3011088743",
          "1420054",
          "3002806559",
          "3016587486",
          "3012494290",
          "3015441043",
          "3011689956",
          "3013557562",
          "3043226252",
          "3002444944"
        ],
        "device_name": "System, Transport, Aerobic",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2900",
        "device_class": "1"
      }
    }
  ]
}