Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical Systems Inc
FDA device recall Z-0553-2008 · posted 2008-01-25 · Terminated
Recall details
- Recalling firm
- Ventana Medical Systems Inc
- Reason for recall
- Fluid Leaks-The T fitting located in the Symphony Clear system of the Symphony High Volume Slide Stainer needs to be larger to securely hold the tubing in place to eliminate any possible fluid leak due to the tubing movement.
- Action taken
- The end user customers were verbally contacted starting in November 2007 to set up a scheduled visit to replace the fitting.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- KEY
- Quantity affected
- 55
- Distribution
- Worldwide-USA, France and Japan
- Date initiated
- 2007-10-30
- Date posted
- 2008-01-25
- Date terminated
- 2008-04-14
- Location
- Tucson, AZ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.