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U.S. Department of Health and Human Services

Class 2 Device Recall EpiCenter Plus Microbiology Data Management System

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 Class 2 Device Recall EpiCenter Plus Microbiology Data Management Systemsee related information
Date Initiated by FirmAugust 25, 2014
Date PostedFebruary 27, 2017
Recall Status1 Terminated 3 on March 08, 2017
Recall NumberZ-1414-2017
Recall Event ID 76498
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
ProductEpiCenter 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.
Code Information Lot Numbers Version 6.20A  Cat. Number 442953 
FEI Number 1119779
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
BD Diagnostic Systems
Sparks MD 21152-9212
For Additional Information Contact
410-316-4000
Manufacturer 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.
FDA Determined
Cause 2		Vendor change control
ActionCustomers 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.
Quantity in CommerceQty Distr. to Field - 115
Distribution15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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