Recall Z-0570-2008
BD Biosciences · initiated September 6, 2007
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.
Codes / lots: Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems.
Reason for recall
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.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-0570-2008
- Initiated
- September 6, 2007
- Posted by FDA
- March 4, 2008
- Terminated
- April 15, 2008
- Product code
- GKZ – Counter, Differential Cell
- Quantity
- 1136 units
- Distribution
- Worldwide Distribution - USA, Belgium, Brazil, Peru, Singapore, Canada, Jamaica, Chile, Ecuador, Hong Kong-China, Thailand, Mexico, Venezuela, Barbados, Philippines, Puerto Rico, Guatemala, Japan, Uruguay, Argentina, China, Trinidad and Tobago, Honduras, Australia, New Zealand, and India.
- Recalling firm
- BD Biosciences, San Jose, CA