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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

Product Description 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.
Recall Number Z-0834-2013
Classification Class II
Code Info 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).
Product Distributed Qty 54 instruments
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 fluid across tubing and wiring within the instrument cabinet resulting in contact with electrical circuitry. This may create shorting conditions and ultimately damage and failure of the component.

Event Detail

Event Id 64244
Product Type Devices
Status Ongoing
Recalling Firm Ventana Medical Systems Inc
City Oro Valley
State AZ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: USA (nationwide) and country of: Germany.
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