{
  "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": [
    {
      "country": "United States",
      "city": "Irvine",
      "address_1": "9755 Research Dr",
      "reason_for_recall": "HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 and lower of a software bug related to the potential for results received being applied to the wrong order in the Lite DM Worklist. This bug has not been seen in software versions above V2.0.0.19    IMPACT: Potential for results received being applied to the wrong order in the Lite DM Worklist.  The is",
      "address_2": "",
      "product_quantity": "322 (5 in U.S. Military)",
      "code_info": "Lot/Serial #(s): N/A  Software Version(s): Versions 2.0.0.19 and lower.  Expiration Date (s): N/A",
      "center_classification_date": "20141223",
      "distribution_pattern": "Nationwide within the U.S.",
      "state": "CA",
      "product_description": "Lite DM (Lite Data Manager)  Software Version(s): Versions 2.0.0.19 and lower  Product Model #: D00A00224D    The Lite DM (Lite Data Manager) is a software application developed by HORIBA  Medical intended to receive, store, and manage Startup, Patient, and Quality Control  (QC) results from an ABX Micros 60 Hematology Analyzer or ABX Micros CRP 200  Hematology Analyzer. Only one instrument connection is allowed per each Lite DM  workstation. The Lite DM application runs on a PC within a Windows Operating  System platform. Data transmitted from the instrument to the Lite DM workstation is a Serial RS-232 unidirectional ABX Format communication. The Lite DM can act as a standalone data manager for data received from the instrument, or allow transmission of this data to a Host (LIS \u0013 Laboratory Information System or EMR \u0013 Electronic Medical Record system).    Following the completion of each blood sample analysis performed on the connected HORIBA Medical hematology analyzer, results are then communicated (uni-directional) to the Lite DM workstation. Results received will display to the user in a specific color coding format indicating any normal or panic reference range violations. Results are then rejected or accepted by the user for final reporting - formatted to guidelines stipulated by CLIA. At no time are any results interpreted; only reported for review and appropriate action.",
      "report_date": "20141231",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Horiba Instruments Inc",
      "recall_number": "Z-0856-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "69847",
      "termination_date": "20150622",
      "more_code_info": "",
      "recall_initiation_date": "20141119",
      "postal_code": "92618-4626",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}