Recall Z-3010-2018 ยท OWF Immunohistochemical Assay, Helicobacter Pylori
Ventana Medical Systems Inc
VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.
| Date | Sep 14, 2018 (initiated Aug 2, 2018) |
| Status | Terminated |
| Reason | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. |
| Root cause | Under Investigation by firm |
| Action | The firm disseminated their field safety notices by letter on 08/02/2018. The firm requested the destruction of the product. |
| Quantity | 2753 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101234 | VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY Ventana Medical Systems, Inc., Aug 25, 2011 |