CINtec p16 Histology — Class I medical device recall Z-3013-2018
Terminated recall by Ventana Medical Systems Inc, reported 2018-09-26. Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC resu
| Recall number | Z-3013-2018 |
|---|---|
| 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 | 240 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04015630984398 |
| Lot numbers | Y16507, Y23040 |
| Model numbers | 06695256001, 825-4713 |
Product
CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
Reason for recall
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
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-3013-2018. 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.