FDAClass ISeptember 26, 2018

iView DAB Detection Kit w/o Secondary Antibody recall

iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.

Why was iView DAB Detection Kit w/o Secondary Antibody 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: Y19981, UDI: 4015630970261

Product
iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.
Recalling firm
Ventana Medical Systems Inc
Quantity
10 units
Distribution
worldwide
Recall date
September 26, 2018
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls