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

Recall Z-0833-2013 — VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; 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-0833-2013
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)
05342716001
Reported risk: Potiential 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. 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 u
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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