Date Initiated by Firm |
August 25, 2014 |
Date Posted |
February 27, 2017 |
Recall Status1 |
Terminated 3 on March 08, 2017 |
Recall Number |
Z-1414-2017 |
Recall Event ID |
76498 |
Product Classification |
Calculator/data processing module, for clinical use - Product Code JQP
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Product |
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.
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Code Information |
Lot Numbers Version 6.20A Cat. Number 442953 |
Recalling Firm/ Manufacturer |
Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems Sparks MD 21152-9212
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For Additional Information Contact |
410-316-4000
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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.
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FDA Determined Cause 2 |
Vendor change control |
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. |
Quantity in Commerce |
Qty Distr. to Field - 115 |
Distribution |
15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors |
Total Product Life Cycle |
TPLC Device Report
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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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