Recall Z-2118-2013
Ventana Medical Systems Inc · initiated June 12, 2008
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: BenchMark XT Instruments-S/N: 711869-712465; BenchMark LT instruments-S/N: 610321-610345. Discovery XT Instruments-S/N: 610321-610345.
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: Device Design
Action taken
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.
Details
- Recall number
- Z-2118-2013
- Initiated
- June 12, 2008
- Posted by FDA
- August 28, 2013
- Terminated
- August 29, 2013
- Product code
- KPA – Slide Stainer, Automated
- Quantity
- 1217 units total
- Distribution
- Worldwide Distribution - USA Nationwide and the countries of Canada, Europe, Asia, Japan.
- Recalling firm
- Ventana Medical Systems Inc, Tucson, AZ