medical Class I Updated 2018-09-26

Ventana Medical Systems Inc recalls VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Num

Recalled Product

VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 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: Y12986, Y16448, Y24119, Y16912Z, UDI: 4015630970018
View official government recall

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