medical Class I Updated 2018-09-26

Ventana Medical Systems Inc recalls CINtec p16 Histology (250) CE, Catalog Number 06695256001, m

Recalled Product

CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 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: Y16507, Y23040, UDI: 4015630984398
View official government recall

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