Device Recall EpiCenter Plus Microbiology Data Management System

  • Modèle / numéro de série
    Lot Numbers Version 6.20A  Cat. Number 442953
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors
  • Description du dispositif
    EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . || Product Usage: || The EpiCenter system is a clinical data management system designed for use with certain BD instrument systems. The EpiCenter system provides advanced capabilities in data management, including extended demographic data, comprehensive reporting features including a powerful database query tool, bi-directional Laboratory Information System (LIS) communications and long-term data storage. Additionally, the EpiCenter system provides an Expert System that can manipulate and/or act upon AST results.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Becton Dickinson & Co., 7 Loveton Cir, BD Diagnostic Systems, Sparks MD 21152-9212
  • Société-mère du fabricant (2017)
  • Source
    USFDA