medical Class I Updated 2018-09-26

Ventana Medical Systems Inc recalls ultraView Universal Alkaline Phosphatase Red Detection Kit,

Recalled Product

ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501 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: Y15071, Y18053, Y22469, UDI: 4015630972258
View official government recall

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