Recall Z-3013-2018 ยท PRB Cervical Intraepithelial Neoplasia (Cin) Test System
Ventana Medical Systems Inc
CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 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 | 240 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.