FDA-Device2013-08-14Class II
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.
Ventana Medical Systems Inc
Hazard
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
Sold states
Worldwide distribution: USA (nationwide) and country of: Germany.
Affected count
54 instruments
Manufactured in
1910 E Innovation Park Dr, N/A, Oro Valley, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0834-2013Don't want to check this manually?
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