Recall Z-0833-2013— Ventana Medical Systems Inc
Class II · Terminated
Class II FDA medical device recall by Ventana Medical Systems Inc, initiated 2012-09-28, terminated 2016-02-24. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 inununohistochemistry or in situ hybridization reagents.. Reason: 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.
- Recalling firm
- Ventana Medical Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-28
- Terminated
- 2016-02-24
- Firm location
- Oro Valley, AZ, United States
Product description
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 inununohistochemistry or in situ hybridization reagents.
Reason for recall
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
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