VENTANA ISH iView Blue Detection Kit — Class I medical device recall Z-3008-2018
Terminated recall by Ventana Medical Systems Inc, reported 2018-09-26. Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers
| Recall number | Z-3008-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ventana Medical Systems Inc, Oro Valley, AZ, United States |
| Recall initiated | 2018-08-02 |
| Classified | 2018-09-14 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2021-11-22 |
| Quantity | 559 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04015630971930 |
| Lot numbers | Y15105, Y22455 |
| Model numbers | 05278511001, 800-092 |
Product
VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
Reason for recall
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3008-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.