FDAClass ISeptember 26, 2018

VENTANA Basal Cell Cktl recall

VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.

Why was VENTANA Basal Cell Cktl recalled?

Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: Y20881, UDI: 4015630984534

Product
VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.
Recalling firm
Ventana Medical Systems Inc
Quantity
75 units
Distribution
worldwide
Recall date
September 26, 2018
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls