Ventana Medical Systems Inc: Medical Device Recall in 2013 - (Recall #: Z-2118-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 12, 2008

Date Posted: September 4, 2013

Recall Number: Z-2118-2013

Event ID: 49516

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.

Status: Terminated

Product Quantity: 1217 units total

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.

Voluntary or Mandated:

Voluntary: Firm initiated