Z-1414-2017Class II

EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the...

Name: Z-1414-2017 EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the...
Creator: Becton Dickinson & Co.
Published: 2014-08-25
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2014-08-25 / Terminated / root cause: supplier

FDA source

Becton Dickinson & Co. began a recall of EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . Product Usage: The... on 2014-08-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1414-2017
Classification: Class II
Status: Terminated
Initiated: 2014-08-25
Posted: 2017-02-27
Terminated: 2017-03-08
Recalling firm: Becton Dickinson & Co
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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: supplier
FDA root cause: 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
Product codes and lots: Lot Numbers Version 6.20A Cat. Number 442953

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1414-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1414-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-08

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)