Company: BD Biosciences
Date of Enforcement Report 8/20/2008
Class:ll
PRODUCT
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
REASON
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.
RECALLING FIRM/MANUFACTURER
BD Biosciences, San Jose, CA, by letter on April 20, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1074 units
DISTRIBUTION
Nationwide
