Z-0553-2008

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

Name: Z-0553-2008 Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical Systems Inc
Creator: Ventana Medical Systems Inc
Published: 2007-10-30
License: https://open.fda.gov/license/

Ventana Medical Systems Inc / initiated 2007-10-30 / Terminated / root cause: design

FDA source

Ventana Medical Systems Inc began a recall of Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical Systems Inc on 2007-10-30. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0553-2008
Status: Terminated
Initiated: 2007-10-30
Posted: 2008-01-25
Terminated: 2008-04-14
Recalling firm: Ventana Medical Systems Inc
Product: Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical Systems Inc
Product code: KEY Stainer, Tissue, Automated
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.
Root cause tag: design
FDA 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 in commerce: 55
Distribution: Worldwide-USA, France and Japan
Product codes and lots: 910044, 910020, 910041, 910060, 910038, 910008, 910048, 910029, 910057, 910006, 910027, 910049, 910036, 910011, 910014, 910056, 910022, 910019, 910016, 910046, 910042, 910007, 910053, 910031, 910021, 910037, 910077, 910032, 910023, 910028, 910034, 910054, 910025, 910045, 910001, 910002, 910015, 910017, 910018, 910026, 910030, 910043, 910004, 910024, 910003, 910047, PP-018, 910040, 910033, 910058, 910059, 910009, 910010, 910013, PP-017

Product code KEY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)