medical Class I Updated 2018-09-26

Ventana Medical Systems Inc recalls VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 064

Recalled Product

VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 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 Number: Y20881, UDI: 4015630984534
View official government recall

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