Recall Z-3007-2018 ยท MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
Ventana Medical Systems Inc
CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 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 | 1719 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110215 | CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY Ventana Medical Systems, Inc., Dec 17, 2012 |