Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS — Class II medical device recall Z-2118-2013
Terminated recall by Ventana Medical Systems Inc, reported 2013-09-04, distributed nationwide. Ventana Medical System is initiating the recall of the BenchMark and DISCOVERY series instruments because ther
| Recall number | Z-2118-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ventana Medical Systems Inc, Tucson, AZ, United States |
| Recall initiated | 2008-06-12 |
| Classified | 2013-08-28 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2013-08-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP |
| Quantity | 1,217 units |
| Model numbers | N750-BMK-FS, N750-BMKLT-FS, N750-BMKXT-FS, N750-DIS-FS, N750-DISXT-FS |
Product
Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry or in situ hybridization reagents for in vitro diagnostic use. The Discovery Systems are research use only instruments with similar functionality.
Reason for recall
Ventana Medical System is initiating the recall of the BenchMark and DISCOVERY series instruments because there is a possibility that the heating element could separate from the underside of the heater cap and cause a non-staining or inconsistent staining event. Additionally, the system may not detect this anomaly and therefore it may not generate an error message for the slide position.
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-2118-2013. 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.