Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0834-2013 — 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 inununohistochemist

U.S. FDA — Device Enforcement · United States · 2012-09-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0834-2013
Date of alert
2012-09-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ventana Medical Systems Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05987750001
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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