Z-1414-2017 Class II Terminated
FDA device recall Z-1414-2017 was initiated by Becton Dickinson & Co. on Aug 25, 2014 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Mar 8, 2017). Affected quantity: Qty Distr. to Field - 115.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 15, 2017
- Initiation Date
- Aug 25, 2014
- Termination Date
- Mar 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Qty Distr. to Field - 115
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.
Reason for Recall
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.
Distribution Pattern
15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors
Code Information
Lot Numbers Version 6.20A Cat. Number 442953
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1414-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026