{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "199239",
      "product_res_number": "Z-1415-2023",
      "event_date_initiated": "2023-03-22",
      "event_date_posted": "2023-04-20",
      "recall_status": "Open, Classified",
      "res_event_number": "91937",
      "product_code": "JTC",
      "product_description": "BD Kiestra InoqulA+ with BD Kiestra\" InoqulA+\" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform.\nAn in vitro diagnostic medical device intended to automate specimen processing according to user-defined procedures and protocols.\nCatalog (Ref) No. : 447213",
      "code_info": "UDI: 038290LSUVLPKFPV\nSerial Numbers:\nINO-000156,\nINO-000249,\nINO-000248,\nINO-000252,\nINO-000254,\n20130276,\n19033ST002",
      "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": "SAME\n410-316-4000",
      "reason_for_recall": "Upon installation of BD Kiestra\" InoqulA+\" and BeA version 5.1 and 5.1.1 as part of the Icefall A platform, plate information was not visible in Synapsys\" after processing has occurred. This could possibly lead to a delayed diagnosis and/or treatment or need for specimen recollection streaking plated media, and inoculating tubes and slides. In Semi-Automated (SA) mode, plates are automatically selected, barcoded, streaked in a pre-configured pattern while the user manually inoculates plates, tubes, and slides. An optional biosafety cabinet on the SA module provides personnel, product, and environmental protection. The InoqulA+\" solution is indicated for use in the clinical laboratory.",
      "root_cause_description": "Software design",
      "action": "BD issued URGENT: Medical Device Product Correction on 3/22/23 via email. Letter states reason for recall,, health risk and action to take:\n1) Read and understand the content of this letter.\n2) Share and post this recall letter within your facility network to ensure awareness.\n3) Customers should utilize the module of the Icefall platform identified by their regional BD service team that does not exhibit this issue to avoid possible unavailability of results.\n4) Complete the attached Customer Response Form and return to the BD contact noted so that BD may acknowledge your receipt of this notification per FDA requirements.\n\nTaken by BD:\n1) BD has developed and remotely implemented an interim solution to immediately address the software issue and prevent disruption of testing for the patients.\n2) BD is taking further action to prevent recurrence of this product issue.\nContact Information:\nUS Contact Information\nAreas of Support\nNorth American Regional Complaint Center, Phone: 1-844-8BD-LIFE (1-844-823-5433)\nSay  Recall  when prompted. Mon Fri 8:00am and 5:00pm CT or\nEmail: productcomplaints@bd.com",
      "product_quantity": "7 instruments",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of IL, NY and the countries of  Netherlands, Saudi Arabia.",
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        ],
        "registration_number": [
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          "3006421415",
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          "3017305295",
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          "3003750284",
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        ],
        "device_name": "Device, Microtiter Diluting/Dispensing",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2500",
        "device_class": "1"
      }
    }
  ]
}