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.
This recall has been terminated (originally issued February 27, 2017).
- Recall Initiated
- August 25, 2014
- Posted
- February 27, 2017
- Terminated
- March 8, 2017
- Recall Number
- Z-1414-2017
- Quantity
- Qty Distr. to Field - 115
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
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
15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors
Lot / Code Info
Lot Numbers Version 6.20A Cat. Number 442953
Root Cause
Vendor change control
Action Taken
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.
More recalls by Becton Dickinson & Co. 7 Loveton Cir Bd Diagnostic Systems
BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX...
Sep 24, 2018
BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare...
Sep 24, 2018
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 49108...
Sep 21, 2018
BD BBL GC-Lect Agar; Cat. No. 297715
The device is a selective medium providing enhanced growth an...
Jun 21, 2018
BD MAX DNA MMK Lab Use, catalog no. 442828
Mar 2, 2018