Recall Z-0570-2008 ยท GKZ Counter, Differential Cell
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.
| Date | Mar 4, 2008 (initiated Sep 6, 2007) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963963 | MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS Becton Dickinson Immunocytometry Systems, Dec 12, 1996 |