medical Class I Updated 2018-09-26

Ventana Medical Systems Inc recalls OptiView DAB IHC Detection Kit, Catalog Number 06396500001,

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Distribution: worldwide
Lot/Code Info: Lot Numbers: Y25760, E00119, Y24225, UDI: 4015630984039
View official government recall

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