VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) f
FDA device recall Z-3010-2018 · 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
- OWF
- Quantity affected
- 2753 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 |
|---|---|---|
| VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY (K101234) | Ventana Medical Systems, Inc. | 2011-08-25 |