FDA Recall
Terminated
iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.
Recall: Z-3001-2018
·
Initiated August 2, 2018
Recall
- Recall Number
- Z-3001-2018
- Event Number
- 80807
- Firm
- Ventana Medical Systems Inc
- FEI Number
- 1000125183
- Product Code
- NJT
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- August 2, 2018
- Posted
- September 14, 2018
- Terminated
- November 22, 2021
- Address
- 1910 E Innovation Park Dr, Oro Valley, AZ, 85755-1962
Description
iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.
Reason
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Action
The firm disseminated their field safety notices by letter on 08/02/2018. The firm requested the destruction of the product.
Distribution
worldwide
Quantity
10 units