Hematoxylin II — Class I medical device recall Z-0738-2018
Terminated recall by Ventana Medical Systems Inc, reported 2018-03-07, distributed nationwide. Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part
| Recall number | Z-0738-2018 |
|---|---|
| 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 | 2017-12-19 |
| Classified | 2018-09-14 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2021-11-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CL, CN, CO, DE, EC, HK, ID, IN, JP, KR, MX, MY, NZ, PE, PH, PK, SG, TH, TW, UY, VN |
| Quantity | 71,640 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04015630972135 |
| Lot numbers | Y10759, Y13938, Y17402, Y17403, Y21312, Y22561 |
| Model numbers | 790-22087 |
Product
Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
Reason for recall
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.
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-0738-2018. 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.