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U.S. Department of Health and Human Services

Class 3 Device Recall Symphony Staining System, KPA

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  Class 3 Device Recall Symphony Staining System, KPA see related information
Date Initiated by Firm October 30, 2007
Date Posted January 25, 2008
Recall Status1 Terminated 3 on April 14, 2008
Recall Number Z-0553-2008
Recall Event ID 45891
Product Classification Staining System - Product Code KEY
Product Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical Systems Inc
Code Information 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
Recalling Firm/
Manufacturer		 Ventana Medical Systems Inc
1910 E Innovation Park Dr
Tucson AZ 85755-1962
For Additional Information Contact Thomas Maloney
520-229-3928
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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