BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, BD Biosciences
FDA device recall Z-0570-2008 · posted 2008-03-04 · Terminated
Recall details
- Recalling firm
- BD Biosciences
- 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.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 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, Uru
- Date initiated
- 2007-09-06
- Date posted
- 2008-03-04
- Date terminated
- 2008-04-15
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS (K963963) | Becton Dickinson Immunocytometry Systems | 1996-12-12 |