Device 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.
Z-2118-2013
Product summary
- Event
- Event 49516
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1217 units total
- Official record key
device-enforcement:Z-2118-2013
Official wording
Reason: 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.
Code information: BenchMark XT Instruments-S/N: 711869-712465; BenchMark LT instruments-S/N: 610321-610345. Discovery XT Instruments-S/N: 610321-610345.
Distribution pattern: Worldwide Distribution - USA Nationwide and the countries of Canada, Europe, Asia, Japan.
Derived failure modes
-
Unknown
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.