Z-0834-2013 Class II Terminated
FDA device recall Z-0834-2013 was initiated by Ventana Medical Systems Inc on Sep 28, 2012 and is designated Class II. 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… The recall status is terminated (terminated Feb 24, 2016). Affected quantity: 54 instruments.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 14, 2013
- Initiation Date
- Sep 28, 2012
- Termination Date
- Feb 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54 instruments
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.
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
Distribution Pattern
Worldwide distribution: USA (nationwide) and country of: Germany.
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).
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0834-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026