FDA Device recall Z-3000-2018
OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use
- FDA Device
- Class I
- terminated
- Published 2018-09-26
On 2018-09-26 the FDA classified a Class I recall of OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use by Ventana Medical Systems, citing leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3000-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-08-02 |
| Published | 2018-09-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ventana Medical Systems |
| Distribution | n/a |
Product
OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.
Reason
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Identifiers
| code_info | Lot Number: Y26282, UDI: 4015630984749 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3000-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.