Device Recall Lite DM (Lite Data Manager)

  • Modelo / Serial
    Lot/Serial #(s): N/A Software Version(s): Versions and lower. Expiration Date (s): N/A
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide within the U.S.
  • Descripción del producto
    Lite DM (Lite Data Manager) || Software Version(s): Versions 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  Laboratory Information System or EMR  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.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Horiba Instruments Inc, 9755 Research Dr, Irvine CA 92618-4626
  • Empresa matriz del fabricante (2017)
  • Source