Company: Becton Dickinson Microbiology Systems
Date of Enforcement Report: 9/25/02
Becton Dickinson’s EpiCenter Data Management System software.
Recall # Z-1338-2.
IVD software defect may cause incorrect patient results to be reported.
EpiCenter Software, version 3.20B, Catalog #441007.
Becton Dickinson Microbiology Systems, Sparks, MD, by letter on August 1, 2002. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally.