Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N75...

FDA Device Recall #Z-2118-2013 - Class II, June 12, 2008

Recall Summary

Recall Number Z-2118-2013
Classification Class II - Moderate risk
Date Initiated June 12, 2008
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ventana Medical Systems Inc
Location Tucson, AZ
Product Type Devices
Quantity 1217 units total

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.

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.

Distribution Pattern

Worldwide Distribution - USA Nationwide and the countries of Canada, Europe, Asia, Japan.

Lot / Code Information

BenchMark XT Instruments-S/N: 711869-712465; BenchMark LT instruments-S/N: 610321-610345. Discovery XT Instruments-S/N: 610321-610345.

Other Recalls from Ventana Medical Systems Inc

Recall # Classification Product Date
Z-1374-2022 Class II Ventana HE 600 System, automated slide preparer... Jun 1, 2022
Z-0894-2022 Class II BenchMark ULTRA and DISCOVERY ULTRA Instruments Jan 20, 2022
Z-2262-2020 Class II Model Number: 06917259001 UDI: 0401563097601... Oct 4, 2019
Z-3014-2018 Class I INFORM HPV III Fam 16 Probe - US Export, Catalo... Aug 2, 2018
Z-2996-2018 Class I OptiView DAB IHC Detection Kit, Catalog Number ... Aug 2, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.