{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Sparks Glencoe",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "76900",
      "recalling_firm": "BD LIFE SCIENCES",
      "address_1": "54 Loveton Cir",
      "address_2": "N/A",
      "postal_code": "21152-9202",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US Distribution to the states of : CA, CO, FL, IL, MN, MO, MT, NE, NJ, NY, OH, OR, PA, TX, TN, WA, WI., and to the countries of : Canada, Hong Kong, Taiwan, Turkey and Europe.    Federal Government Agency sales/distribution centers or foreign countries    VA Fort Harrison and VAMC Austin.",
      "recall_number": "Z-1864-2017",
      "product_description": "Software version 4.44A utilized on the BD MAX System",
      "product_quantity": "There are 29 US customers and 5 ex-US regions with a BD MAX System running software version 4.44A.",
      "reason_for_recall": "The BD MAX System software version 4.44A contains a software anomaly that has the potential to affect some Open System Reagent (OSR) customers utilizing User Defined Protocol (UDP) assays. Customers utilizing only IVD assays are not affected.    This anomaly may cause the OSR customer system to incorrectly switch the columns of the truth table on the user\u0019s display. If the user tries to fix their display data, the display will appear correct however, the database may become incorrect, potentially resulting in incorrect results reporting.    BD is able to trace the issue to a limited number of instruments that have software version 4.44A installed.  Note that the problem only affects customers that are either creating a new UDP with Result Logic or modifying the Result Logic of an existing UDP.",
      "recall_initiation_date": "20150729",
      "center_classification_date": "20170419",
      "termination_date": "20170419",
      "report_date": "20170426",
      "code_info": "Catalog number 441916"
    }
  ]
}