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U.S. Department of Health and Human Services

Class 2 Device Recall Benchmark & Discovery

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 Class 2 Device Recall Benchmark & Discoverysee related information
Date Initiated by FirmJune 12, 2008
Date PostedAugust 28, 2013
Recall Status1 Terminated 3 on August 29, 2013
Recall NumberZ-2118-2013
Recall Event ID 49516
Product Classification Slide stainer, automated - Product Code KPA
ProductBenchmark 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.
Code Information BenchMark XT Instruments-S/N: 711869-712465; BenchMark LT instruments-S/N: 610321-610345. Discovery XT Instruments-S/N: 610321-610345.
Recalling Firm/
Manufacturer		 Ventana Medical Systems Inc
1910 E Innovation Park Dr
Tucson AZ 85755
For Additional Information Contact
520-229-3928
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionVentana 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 Commerce1217 units total
DistributionWorldwide Distribution - USA Nationwide and the countries of Canada, Europe, Asia, Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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