CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325
FDA device recall Z-3007-2018 · 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
- MYA
- Quantity affected
- 1719 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
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY (K110215) | Ventana Medical Systems, Inc. | 2012-12-17 |