Recall Z-0553-2008 ยท KEY Stainer, Tissue, Automated
Ventana Medical Systems Inc
Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical Systems Inc
| Date | Jan 25, 2008 (initiated Oct 30, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | The end user customers were verbally contacted starting in November 2007 to set up a scheduled visit to replace the fitting. |
| Quantity | 55 |
| Distribution | Worldwide-USA, France and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.