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Terminated

Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical Systems Inc

FDA Recall Z-0553-2008 · Posted 2008-01-25

Recalling FirmVentana Medical Systems Inc
Recall StatusTerminated
Product CodeKEY
Date Initiated2007-10-30
Date Terminated2008-04-14
Product Quantity55

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.

Firm Action

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

Distribution Pattern

Worldwide-USA, France and Japan

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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