Events

Recall of Symphony Staining System, KPA

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ventana Medical Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    45891
  • Event Risk Class
    Class 3
  • Event Number
    Z-0553-2008
  • Event Initiated Date
    2007-10-30
  • Event Date Posted
    2008-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66420
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Staining System - Product Code KEY
  • 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.
  • Action
    The end user customers were verbally contacted starting in November 2007 to set up a scheduled visit to replace the fitting.

Device

Symphony Staining System, KPA
  • Model / Serial
    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 Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide-USA, France and Japan
  • Product Description
    Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical Systems Inc
  • Manufacturer
    Ventana Medical Systems Inc

Manufacturer

Ventana Medical Systems Inc
  • Manufacturer Address
    Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Tucson AZ 85755-1962
  • Manufacturer Parent Company (2017)
    Roche Holding Ag
  • Source
    USFDA