FDAFDA · Alimentos y medicamentos·N.º oficial Z-1414-2017
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.
Publicado el 15 de marzo de 2017 · Inicio del retiro: 25 de agosto de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The information in the EpiCenter interface translation tables was not updated to match the Bruker MALDI BioTyper database identifications for some organisms. This could lead to a possible mis-identification of an organism.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Becton Dickinson & Co.
- Distribuidor
- 15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors
- Lote
- Lot Numbers Version 6.20A Cat. Number 442953
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.