CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-
FDA device recall Z-3006-2018 · 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
- MXZ
- Quantity affected
- 1655 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.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY (K103818) | Ventana Medical Sytems, Inc. | 2011-11-16 |