Company: BD Biosciences,
Date of Enforcement Report 3/12/2008
BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, Recall # Z-0570-2008
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.
BD Biosciences, San Jose, CA, by letter on September 14, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally