Home / Recalls / Ventana Medical Systems Inc / Z-3000-2018

Z-3000-2018 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
461 units

Product Description

OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 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 Number: Y26282, UDI: 4015630984749

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