Becton Dickinson & Co. recalls EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioT…

Recall date

August 25, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1414-2017

FDA classification

Class II

Brand / firm

Becton Dickinson & Co.

Sold / distributed

15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.