Recall Z-3006-2018 ยท MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor
Ventana Medical Systems Inc
CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 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 | 1655 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103818 | CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY Ventana Medical Sytems, Inc., Nov 16, 2011 |