PlainRecalls
FDA Devices Moderate Class II Terminated

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) co

Reported: March 15, 2017 Initiated: August 25, 2014 #Z-1414-2017

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.

Details

Recalling Firm
Becton Dickinson & Co.
Units Affected
Qty Distr. to Field - 115
Distribution
15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors
Location
Sparks, MD

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Becton Dickinson & Co.. Units affected: Qty Distr. to Field - 115.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 15, 2017. Severity: Moderate. Recall number: Z-1414-2017.

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