BD Biosciences Cytometry Class II

Company: BD Biosciences,
Date of Enforcement Report 3/12/2008
Class:ll

PRODUCT
BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, Recall # Z-0570-2008

REASON
Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the lymph gate or attractors in the Lab Report view without using the Manual Gate function (as described in the system manual), the statistic results will not be updated to match the adjusted gate.

RECALLING FIRM/MANUFACTURER
BD Biosciences, San Jose, CA, by letter on September 14, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,136 units

DISTRIBUTION
Nationwide and Internationally

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.