Home / Recalls / Ventana Medical Systems Inc / Z-2996-2018

Z-2996-2018 Class I Terminated

Recalled by Ventana Medical Systems Inc — Oro Valley, AZ

Recall Details

Product Type
Devices
Report Date
September 26, 2018
Initiation Date
August 2, 2018
Termination Date
November 22, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,712 units

Product Description

OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use.

Reason for Recall

Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.

Distribution Pattern

worldwide

Code Information

Lot Numbers: Y25760, E00119, Y24225, UDI: 4015630984039

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