OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagno
FDA device recall Z-2996-2018 · posted 2018-09-14 · Terminated
Recall details
- Recalling firm
- Ventana Medical Systems Inc
- Reason for recall
- Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
- Action taken
- The firm disseminated their field safety notices by letter on 08/02/2018. The firm requested the destruction of the product.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- NJT
- Quantity affected
- 11,712 units
- Distribution
- worldwide
- Date initiated
- 2018-08-02
- Date posted
- 2018-09-14
- Date terminated
- 2021-11-22
- Location
- Oro Valley, AZ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.