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
