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U.S. Department of Health and Human Services

Class 2 Device Recall Discovery Ultra Advanced Staining System Research Use Only (RUO)

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  Class 2 Device Recall Discovery Ultra Advanced Staining System Research Use Only (RUO) see related information
Date Initiated by Firm September 28, 2012
Date Posted August 06, 2013
Recall Status1 Terminated 3 on February 24, 2016
Recall Number Z-0834-2013
Recall Event ID 64244
Product Classification Slide stainer, automated - Product Code KPA
Product VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only


Product Usage:
Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents.
Code Information Cat#750-601; PN 05987750001; Serial #'s: 310646, 311573, 310477, 311725, 311042, 311623, 312032, 312159, 310615, 310837, 311862, 311043 311572, 311766, 310526, 311011, 311185, 311723, 312082, 310635, 311574, 312084, 310636, 310835, 311179, 310493, 311183, 311769, 311930, 311962, 311963, 310437, 311965, 310997, 311726, 311620, 311512, 311526, 312083, 310468, 310759 (All serial numbers in the market).
Recalling Firm/
Manufacturer		 Ventana Medical Systems Inc
1910 E Innovation Park Dr
Oro Valley AZ 85755-1962
For Additional Information Contact Robert D. Brooks
520-877-7191
Manufacturer Reason
for Recall		 Potential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform.The waste fluid drainage system may become restricted by build-up of debris in the tubing and in-line filter, thereby inhibiting optimal flow rates. This type of overflow event can lead to migration of flu
FDA Determined
Cause 2		 Device Design
Action The firm, Roche sent a "Technical Bulletin" and an letter dated October 3, 2012 to its customers. The letter and bulletin described the product, problem and actions to be taken. The customers were informed that Ventana is aggressively working on solutions to this issue. Until mitigations to the overflow condition are available for implementation; inform all personnel in your organization that work with the BenchMark ULTRA or DISCOVERY ULTRA instrument about the potential for fluid overflow to occur during decontamination cycles; follow the instructions provided in the letter to avoid the documented failure mode and follow the instructions provided in the technical bulletin. Contact your local support center with any questions or concerns or call 520-877-7191.
Quantity in Commerce 54 instruments
Distribution Worldwide distribution: USA (nationwide) and country of: Germany.
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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