FDAAugust 25, 2014device

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...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

becton dickinsonbectonbecton dickinson

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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