Devices

Device Recall EpiCenter Plus Microbiology Data Management System

Model / Serial
Lot Numbers Version 6.20A Cat. Number 442953
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors
Product Description
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
Becton Dickinson & Co.
1 Event
- Recall of Device Recall EpiCenter Plus Microbiology Data Management System

Manufacturer

Becton Dickinson & Co.

Manufacturer Address
Becton Dickinson & Co., 7 Loveton Cir, BD Diagnostic Systems, Sparks MD 21152-9212
Manufacturer Parent Company (2017)
Becton, Dickinson and Company
Source
USFDA

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