medical Class I Updated 2018-09-26

Ventana Medical Systems Inc recalls INFORM HPV III Fam 16 Probe - US Export, Catalog Number 0527

Recalled Product

INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 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: Y19417, UDI: 4015630972210
View official government recall

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