Reported Sep 4, 2013 · Terminated
Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS.…
Ventana Medical Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ventana Medical Systems Inc · 1910 E Innovation Park Dr · Tucson, AZ · 85755
Is this the product you have?
- Benchmark
- XT/LT and Discovery XT Model Numbers
N750-BMK-FSN750-BMKXT-FSN750-BMKLT-FSN750-DIS-FSN750-DISXT-FS
- Product UsageUsage: 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
- Lot codes and dates
- BenchMark XT Instruments-S/N711869-712465
- BenchMark LT instruments-S/N610321-610345
- Discovery XT Instruments-S/N610321-610345
- Amount recalled
- 1217 units total
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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