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.
FDA Recall Z-1414-2017 · Posted 2017-02-27
Advertisement
Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeJQP
Date Initiated2014-08-25
Date Terminated2017-03-08
Product QuantityQty Distr. to Field - 115
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.
Firm 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.
Root Cause
Vendor change control
Distribution Pattern
15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement