Events

Recall of Device Recall EpiCenter Plus Microbiology Data Management System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Co..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76498
  • Event Risk Class
    Class 2
  • Event Number
    Z-1414-2017
  • Event Initiated Date
    2014-08-25
  • Event Date Posted
    2017-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153374
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    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.
  • Action
    Customers were initially contacted via phone calls and subsequently provided with a written communication. For questions contact BD Technical Services Department at 1-800-638-8663.

Device

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.

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