BenchMark GX
Catalogue number 05894662001, listed by Ventana Medical Systems, Inc., United States, under Slide Stainer, Automated. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
1catalogue number
11recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Shandong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
| Leica Instruments (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 11 |
| Dakewe(Shenzhen) Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 9 |
| Henan Celnovte Biotechnology Co., Ltd. | Zhengzhou | Henan | Manufacturer | 8 |
| Hangzhou Healthsky Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
| Jiangsu Medomics Medical Technology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 14. All 14 manufacturers in China registered for Slide Stainer, Automated
Record
| Listed by | Ventana Medical Systems, Inc., United States |
|---|---|
| FDA product code | KPA |
| Device type | Slide Stainer, Automated |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3800 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-12-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 05894662001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Shandon Diagnostics Limited | 54 |
| Thermo Fisher | Shandon Diagnostics Limited | 27 |
| Bond | Leica Biosystems Melbourne PTY Ltd | 21 |
| HistoPro® | Rushabh Instruments, LLC | 5 |
| intelliPATH Plus | Biocare Medical, LLC | 4 |
| Alinity | Abbott Laboratories | 4 |
| intelliPATH MAX | Biocare Medical, LLC | 4 |
| Bond | Leica Biosystems Newcastle Ltd | 4 |
| Dako | Agilent Technologies, Inc | 3 |
| Advia Autoslide® Slide Maker Stainer | Siemens Healthcare Diagnostics Inc | 3 |
| Bond-Prime automated stainer | Leica Biosystems Melbourne PTY Ltd | 2 |
| Decloaking Chamber™ NxGen Reconditioned | Biocare Medical, LLC | 2 |
Showing 12 of 153. All products under Slide Stainer, Automated
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-06-01 | Class II | Under Investigation by firm | There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire | 763 instruments | |
| 2022-01-20 | Class II | Device Design | Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board’s J1 Connector that could result in smoke and fire. | 9214 | |
| 2019-10-04 | Class II | Under Investigation by firm | The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology laboratory settings, which caused fluid to travel down to | 461 | |
| 2012-09-28 | Class II | Device Design | Potiential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform. This type of overflow event can lead to mig | 1735 instruments | 2016-02-24 |
| 2012-09-28 | Class II | Device Design | Potential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform.The waste fluid drainage system may become re | 54 instruments | 2016-02-24 |
| 2008-06-12 | Class II | Device Design | 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 incons | 1217 units total | 2013-08-29 |
| 2006-09-29 | Not classified | Device Design | Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed. | USA – 1,712 units; Foreign – 1,159 units (total for recalls- | 2013-06-06 |
| 2006-09-29 | Not classified | Device Design | Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed. | USA – 1,712 units; Foreign – 1,159 units (total for recalls- | 2013-06-06 |
| 2006-09-29 | Not classified | Device Design | Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed. | USA – 1,712 units; Foreign – 1,159 units (total for recalls- | 2013-06-06 |
| 2006-09-29 | Not classified | Device Design | Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed. | USA – 1,712 units; Foreign – 1,159 units (total for recalls- | 2013-06-06 |
| 2006-09-29 | Not classified | Device Design | Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed. | USA – 1,712 units; Foreign – 1,159 units (total for recalls- | 2013-06-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.