BD Biosciences BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, BD Biosciences, San Jose, CA 95131. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, BD Biosciences, San Jose, CA 95131.
Brand
BD Biosciences
Lot Codes / Batch Numbers
Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems.
Products Sold
Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems.
BD Biosciences is recalling BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating sys due to Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the lymph gate or attractors in the Lab Repor. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Becton Dickinson sent an Important Product Information letter by mail on 09/14/2007 informing customers of the need to follow the instructions for adjusting the lymph gate or attractors. The next software revision will alleviate this limitation.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026