Recall Z-1414-2017— Becton Dickinson & Co.

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2014-08-25, terminated 2017-03-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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..

Recalling firm

Becton Dickinson & Co.

Classification

Class II

Status

Terminated

Initiated

2014-08-25

Terminated

2017-03-08

Firm location

Sparks, MD, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.