Z-2118-2013Class II

Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS...

Name: Z-2118-2013 Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS...
Creator: Ventana Medical Systems Inc
Published: 2008-06-12
License: https://open.fda.gov/license/

Ventana Medical Systems Inc / initiated 2008-06-12 / Terminated / root cause: design

FDA source

Ventana Medical Systems Inc began a recall of 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... on 2008-06-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2118-2013
Classification: Class II
Status: Terminated
Initiated: 2008-06-12
Posted: 2013-08-28
Terminated: 2013-08-29
Recalling firm: Ventana Medical Systems Inc
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.
Product code: KPA Slide Stainer, Automated
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.
Root cause tag: design
FDA root cause: Device Design
Action: Ventana sent an Urgent Medical Device Correction Notification letter dated June 16, 2008 to all affected customers. The letter identifed the affected product, problem and actions to be taken. The letter instructed customers to carefully read and perform all of the actions outlined in the notification letter concerning potential safety issue. Customers with concerns regarding the staining results on any patient specimen are instructed to follow their internal Quality Procedures regarding the review of patient reports. For question contact your local Customer Service Center.
Quantity in commerce: 1217 units total
Distribution: Worldwide Distribution - USA Nationwide and the countries of Canada, Europe, Asia, Japan.
Product codes and lots: BenchMark XT Instruments-S/N: 711869-712465; BenchMark LT instruments-S/N: 610321-610345. Discovery XT Instruments-S/N: 610321-610345.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2118-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2118-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-28

Product code KPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)