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