Cl Il BD FACSDiva Software v4.0.1 to 5.0.2

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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.