FDAFDA · Food and drugs·Recall number Z-2118-2013
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.
Published September 4, 2013 · Recall initiated: June 12, 2008
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ventana Medical Systems Inc
- Distributor
- Worldwide Distribution - USA Nationwide and the countries of Canada, Europe, Asia, Japan.
- Lot
- BenchMark XT Instruments-S/N: 711869-712465; BenchMark LT instruments-S/N: 610321-610345. Discovery XT Instruments-S/N: 610321-610345.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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