{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Sparks",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "95394",
      "recalling_firm": "Becton Dickinson & Co.",
      "address_1": "7 Loveton Cir",
      "address_2": "",
      "postal_code": "21152-9212",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Foreign: Australia, New Zealand, Singapore, Hong Kong, Taiwan, Japan, Austria, Belgium, Denmark, France, Germany, Italy, Luxembourg, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, Russia, Saudi Arabia, South Africa, Canada,  Mexico, China",
      "recall_number": "Z-0026-2025",
      "product_description": "BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30-  IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place.  Catalog Number: 444150",
      "product_quantity": "162 units",
      "reason_for_recall": "Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI or EUCAST. This occurs when the identified organism is included in the same interpretive group as a species for which there is a specific breakpoint. May result in either a false susceptible or false resistant result. A false susceptible result can cause inadequate or incomplete antibiotic treatment due to the use of an ineffective antibiotic, and a false resistant result may limit access to a preferred antibiotic regimen with possible elongation of therapy",
      "recall_initiation_date": "20240912",
      "center_classification_date": "20241008",
      "report_date": "20241016",
      "code_info": "UDI-DI: 00382904441500 Software versions: 4.20, 4.30, 5.10, 5.20 and 5.30",
      "more_code_info": ""
    }
  ]
}