PlainRecalls
FDA Devices Critical Class I Terminated

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

Reported: September 26, 2018 Initiated: August 2, 2018 #Z-3001-2018

Product Description

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

Reason for Recall

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

Details

Units Affected
10 units
Distribution
worldwide
Location
Oro Valley, AZ

Frequently Asked Questions

What product was recalled?
iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.. Recalled by Ventana Medical Systems Inc. Units affected: 10 units.
Why was this product recalled?
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 26, 2018. Severity: Critical. Recall number: Z-3001-2018.