{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "36692",
      "product_res_number": "Z-0455-05",
      "event_date_initiated": "2005-01-10",
      "event_date_posted": "2005-02-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-04-19",
      "res_event_number": "30844",
      "product_code": "LSL",
      "product_description": "BD ProbeTec ET Urine Processing Kit, 4x25, catalog 440454, packaged in a carton containing 4 storage bags identified as BD ProbeTec ET Urine Processing Pouches, 25 pouches/bag. Carton and bags labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152***",
      "code_info": "Lot/Exp 4103719\t\tOctober 31, 2005 4118463\t\tOctober 31, 2005 4119670\t\tNovember 30, 2005 4124224\t\tNovember 30, 2005 4133122\t\tNovember 30, 2005 4105126\t\tOctober 31, 2005 4118129\t\tNovember 30, 2005 4104256\t\tOctober 31, 2005 4091913\t\tOctober 31, 2005 4104254\t\tOctober 31, 2005 4090438\t\tOctober 31, 2005 4090259\t\tOctober 31, 2005 4084784\t\tOctober 31, 2005 4014879\t\tJuly 31, 2005 4016963\t\tJuly 31, 2005 4023837\t\tJuly 31, 2005 4023840\t\tAugust 31, 2005 4041551\t\tAugust 31, 2005 4083445\t\tOctober 31, 2005 4133902\t\tNovember 30, 2005",
      "firm_fei_number": "1119779",
      "recalling_firm": "Becton Dickinson & Co.",
      "address_1": "7 Loveton Cir",
      "city": "Sparks",
      "state": "MD",
      "postal_code": "21152-9212",
      "additional_info_contact": "BD Technical Service\n800-666-6433 Ext. 4331",
      "reason_for_recall": "An in-vitro diagnostic kit reagent may cause false negative clinical results in patients tested for sexually transmitted infections.",
      "root_cause_description": "Other",
      "action": "BD notified consignees by phone on 01/10/05 and advised that users transporting patient urine samples may experience increased indeterminate results or false negative results when testing the samples on the BD ProbeTec ET CT/GC Amplified DNA Assay. Subsequest to the phone notification, kit users identified as utilizing the Urine Processing Pouches were further notified by a letter. The letter describes 4 criteria contributing to the risk associated with false negative and indeterminate results. The letter advised users to discontinue use of the kits and discard for replacement. \n\nBD further advised in the notification that if the user is not utilizing the Amplification Control (AC), the firm recommends that they evaluate if urine specimens were transported and/or stored at refrigerated temperatures in the kit''s urine pouches.  If specimens were transported and/or stored under the noted criteria, BD recommends that users should notify physicians who received reports of negative patient results and indicate that there is a possibility that these results were incorrect.  BD plans to provide a 'Dear Physician' letter that would facilitate that notification upon request of the users.",
      "product_quantity": "2175 kits",
      "distribution_pattern": "Product was distributed to direct accounts in the US and to affiliated distributors internationally.",
      "openfda": {
        "k_number": [
          "K140887",
          "K111409",
          "K043224",
          "K043144",
          "K140448",
          "K935833",
          "K974342",
          "K180681",
          "K231329",
          "K981485",
          "K895583",
          "K032194",
          "K874620",
          "K173887",
          "K920301",
          "K163184",
          "K003395",
          "K981567",
          "K140354",
          "K132270",
          "K132251",
          "K063664",
          "K991268",
          "K984631",
          "K070172",
          "K121710",
          "K010893",
          "K081825",
          "K872628",
          "K052224",
          "K173840",
          "K090971",
          "K032554",
          "K883486",
          "K090827",
          "K974503",
          "K091730",
          "K060652",
          "K881277",
          "K940979",
          "K012351",
          "K062440",
          "K061509",
          "K053289",
          "K052481"
        ],
        "registration_number": [
          "3018348",
          "3025663244",
          "3005248192",
          "3012494290",
          "2024800",
          "3017907743",
          "2029275",
          "3012598266",
          "3006198300",
          "1550222",
          "3043226252",
          "3004141078",
          "3002444944",
          "2436875",
          "9610126",
          "3009613136",
          "1119779",
          "2243471",
          "3016838963",
          "3016608638",
          "3013019728",
          "1122376",
          "3007420875",
          "3004530258",
          "3038610665",
          "3003795116",
          "3019837962",
          "3026940910"
        ],
        "fei_number": [
          "3003572099",
          "3002806559",
          "3018348",
          "3025663244",
          "3005248192",
          "3012494290",
          "2024800",
          "3017907743",
          "3012598266",
          "3006198300",
          "1000521444",
          "1000306431",
          "1550222",
          "3004141078",
          "3043226252",
          "3002444944",
          "3009613136",
          "1119779",
          "2243471",
          "3016838963",
          "3016608638",
          "3013019728",
          "3007420875",
          "3004530258",
          "3038610665",
          "3003795116",
          "3019837962",
          "3026940910"
        ],
        "device_name": "Dna-Reagents, Neisseria",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3390",
        "device_class": "2"
      }
    }
  ]
}