Slide Stainer, Automated
FDA product code KPA · Class I (low risk) · 21 CFR 864.3800 · Pathology
21510(k) clearances
0PMA approvals
30recalls
Manufacturers
- Innovative Medical Systems, Inc. 4
- Wescor, Inc. 2
- Shaban Mfg. Co. 2
- American Bionetics, Inc. 2
- Jack W. Kindberg 1
- Miles Laboratories, Inc. 1
- American Safety Equipment Corp. 1
- Honeywell, Inc. 1
- A. J. P. Scientific, Inc. 1
- Technicon Instruments Corp. 1
- Tomtec 1
- Radiological Engineering, Inc. 1
- Fisher Scientific Co., LLC 1
- Sakura Finetek U.S.A., Inc. 1
- Tecan U.S., Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933996 | ProfiblotKPA · Traditional | Tecan U.S., Ltd. | 01/28/1994SE |
| K884258 | VersablotKPA · Traditional | American Bionetics, Inc. | 12/14/1988SE |
| K881592 | Wescor Model 7300 Aerospray Gram StainerKPA · Traditional | Wescor, Inc. | 05/13/1988SE |
| K880745 | LX-100 Slide StainerKPA · Traditional | Innovative Medical Systems, Inc. | 04/27/1988SE |
| K874887 | Wesblot ProcessorKPA · Traditional | American Bionetics, Inc. | 03/24/1988SE |
| K874897 | Sakura DRS-60 Automatic Slide StainerKPA · Traditional | Sakura Finetek U.S.A., Inc. | 01/05/1988SE |
| K872916 | Histomatic Slide Stainer, Code-On VersionKPA · Traditional | Fisher Scientific Co., LLC | 09/14/1987SE |
| K853210 | MST-1050-II X-Ray UnitKPA · Traditional | Radiological Engineering, Inc. | 10/10/1985SE |
| K850333 | Pump Tube Sets for Hema-Tek I & II Slide StainersKPA · Traditional | Shaban Mfg. Co. | 02/27/1985SE |
| K850157 | Cannulas for Hema-Tek I & KK Slide StainersKPA · Traditional | Shaban Mfg. Co. | 02/27/1985SE |
| K842077 | Midas II Automatic StainerKPA · Traditional | Innovative Medical Systems, Inc. | 07/27/1984SE |
| K833295 | Wescor 7100 Aerospray Slide StainerKPA · Traditional | Wescor, Inc. | 10/31/1983SE |
| K832994 | Midas 6000 Automatic StainerKPA · Traditional | Innovative Medical Systems, Inc. | 09/29/1983SE |
| K821830 | Mi Das 1000 Automatic Slide StainerKPA · Traditional | Innovative Medical Systems, Inc. | 07/22/1982SE |
| K811697 | GuamstainerKPA · Traditional | Tomtec | 07/02/1981SE |
| K781598 | Technicon Autoslide Staining/ProcessingKPA · Traditional | Technicon Instruments Corp. | 10/17/1978SE |
| K780637 | Hematology Slide StainerKPA · Traditional | A. J. P. Scientific, Inc. | 05/19/1978SE |
| K780017 | Auto. Slide StainerKPA · Traditional | Honeywell, Inc. | 01/30/1978SE |
| K771699 | Cara-Stain Model 3000KPA · Traditional | American Safety Equipment Corp. | 09/13/1977SE |
| K771559 | Hema-Tek II Slide StainerKPA · Traditional | Miles Laboratories, Inc. | 08/25/1977SE |
| K770076 | Bio-Dyes Fort. Wrights Stain Hemat. PackKPA · Traditional | Jack W. Kindberg | 03/22/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1919-2024 Class II | Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer…There is the potential for the front plexiglass door of the automated slide processing system to break… | Agilent Technologies | 04/02/2024Open, Classified |
| Z-1374-2022 Class II | Ventana HE 600 System, automated slide preparer, for use in laboratories.There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical… | Ventana Medical Systems Inc | 06/01/2022Open, Classified |
| Z-0894-2022 Class II | BenchMark ULTRA and DISCOVERY ULTRA InstrumentsPotential for Fluid Leak inside a staining system that could cause an electrical short circuit of the… | Ventana Medical Systems Inc | 01/20/2022Open, Classified |
| Z-1835-2021 Class II | Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism… | Hardy Diagnostics | 04/16/2021Terminated |
| Z-1333-2021 Class II | BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model…Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with… | Biocare Medical, LLC | 02/25/2021Terminated |
| Z-0086-2021 Class II | DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number:…Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket… | Roche Diagnostics Operations, Inc. | 08/31/2020Open, Classified |
| Z-0085-2021 Class II | BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket… | Roche Diagnostics Operations, Inc. | 08/31/2020Open, Classified |
| Z-2074-2020 Class II | Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link…The Autostainer instrument may not have a syringe tray installed which could result in a small volume of… | Dako Denmark A/S | 11/05/2019Terminated |
| Z-2262-2020 Class II | Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use…The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE… | Ventana Medical Systems Inc | 10/04/2019Completed |
| Z-0281-2019 Class II | BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III…The power supply unit for the printer used with the device can potentially overheat or cause a fire hazard… | Leica Microsystems, Inc. | 09/17/2018Terminated |
| Z-0064-2019 Class II | Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The…These devices have an incorrect specification against safety standard ISO61010-1. Should a single fault… | Leica Microsystems, Inc. | 06/13/2018Terminated |
| Z-2170-2018 Class II | The PREVI Color Gram dyes are used with the PREVI Color Gram instrument to stain…A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits.… | BioMerieux SA | 03/23/2018Terminated |
| Z-2146-2016 Class II | QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains…Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper… | Hardy Diagnostics | 05/24/2016Terminated |
| Z-1548-2015 Class II | Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis…If a user requests slides from the LIS or TPID, then updates a request by changing the test, the TRD… | Dako North America Inc. | 04/01/2015Terminated |
| Z-1261-2015 Class II | Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer…A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopcock… | Dako North America Inc. | 02/12/2015Terminated |
| Z-2708-2014 Class II | Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product…Dako is recalling the Dako Link 4.0.3 software on the Dako Autostainer Link 48 because Dako has determined… | Dako North America Inc. | 08/29/2014Terminated |
| Z-0563-2013 Class II | CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer…The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance… | Dako Denmark A/S | 11/26/2012Terminated |
| Z-0834-2013 Class II | VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only…Potential for a waste fluid overflow condition to accur while running decontamination cycles on the… | Ventana Medical Systems Inc | 09/28/2012Terminated |
| Z-0833-2013 Class II | VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only…Potiential for a waste fluid overflow condition to accur while running decontamination cycles on the… | Ventana Medical Systems Inc | 09/28/2012Terminated |
| Z-2226-2012 Class II | UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Slidemaker…The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Floor Stand… | Beckman Coulter Inc. | 12/13/2011Terminated |
| Z-2313-2010 | VP 2000 Processor Heated Reagent Basins; automated slide stainer; Abbott Molecular Inc.…The VP2000 Processor Heated Reagent Basins crack along the bottom seam, have non-uniform coating of interior… | Abbott Molecular | 07/20/2010Terminated |
| Z-2118-2013 Class II | Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS…Ventana Medical System is initiating the recall of the BenchMark and DISCOVERY series instruments because… | Ventana Medical Systems Inc | 06/12/2008Terminated |
| Z-0851-2010 | GEN*S SlideMaker, Barcode Label Specifications, GEN*S SM Intended Use, GEN*S Slide and…Beckman Coulter has become aware of a potential issue in which the Sample ID information embedded in the… | Beckman Coulter Inc | 05/29/2008Terminated |
| Z-0850-2010 | COULTER LH SlideMaker, LH Barcode Specification, LH SM Intended Use, LH Slide and Sample…Beckman Coulter has become aware of a potential issue in which the Sample ID information embedded in the… | Beckman Coulter Inc | 05/29/2008Terminated |
| Z-0199-2007 | Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, Dako Colorado…Automated slide staining device may not stain speciman slides correctly, and therefore slides cannot be used… | Dako Colorado, Inc. | 10/02/2006Terminated |
| Z-0541-2008 | Discovery XT, Slide Staining System, Catalog Number: N750-DISXT-FS, Ventana Medical…Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the… | Ventana Medical Systems Inc | 09/29/2006Terminated |
| Z-0540-2008 | Discovery, Slide Staining System, Catalog Number: N750-DIS-FS, Ventana Medical Systems…Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the… | Ventana Medical Systems Inc | 09/29/2006Terminated |
| Z-0539-2008 | Benchmark LT, Slide Staining System, Catalog Number: N750-BMKLT-FS, Ventana Medical…Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the… | Ventana Medical Systems Inc | 09/29/2006Terminated |
| Z-0538-2008 | Benchmark XT, Slide Staining System, Catalog Number: N750-BMKXT-FS, Ventana Medical…Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the… | Ventana Medical Systems Inc | 09/29/2006Terminated |
| Z-0537-2008 | Benchmark, Slide Staining System, Catalog Number: N750-BMK-FS, Ventana Medical Systems…Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the… | Ventana Medical Systems Inc | 09/29/2006Terminated |