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

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

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