Company: BD Biosciences
Date of Enforcement Report 8/20/2008
FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. Catalog number 641609 Flexible data acquisition and analysis package specifically designed for digital-based flow cytometers; Recall # Z-1525-2008
When data file containing one or no fluoresence parameters is exported, the software will automatically apply compensation to this file and all subsequently exported files.
BD Biosciences, San Jose, CA, by letter on April 20, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE