medical Class I Updated 2018-09-26

Ventana Medical Systems Inc recalls CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal

Recalled Product

CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 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: Y18586, Y24472, UDI: 4015630972234
View official government recall

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