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

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020

To pre-register and get info on deep discounts or if you have questions, email training@softwarecpr.com

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+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.