VENTANA — Class II medical device recall Z-0834-2013
Terminated recall by Ventana Medical Systems Inc, reported 2013-08-14, distributed nationwide. Potential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark
| Recall number | Z-0834-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ventana Medical Systems Inc, Oro Valley, AZ, United States |
| Recall initiated | 2012-09-28 |
| Classified | 2013-08-06 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2016-02-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE |
| Quantity | 54 instruments |
| Serial numbers | 310437, 310468, 310477, 310493, 310526, 310615, 310635, 310636, 310646, 310759, 310835, 310837, 310997, 311011, 311042, 311043, 311179, 311183, 311185, 311512, 311526, 311572, 311573, 311574, 311620 and 16 more |
| Model numbers | 750-601 |
Product
VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents.
Reason for recall
Potential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform.The waste fluid drainage system may become restricted by build-up of debris in the tubing and in-line filter, thereby inhibiting optimal flow rates. This type of overflow event can lead to migration of flu
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-0834-2013. 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.