Processor, Tissue, Automated
FDA product code IEO · Class I (low risk) · 21 CFR 864.3875 · Pathology
12510(k) clearances
0PMA approvals
11recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K924590 | Microwave Automated Tissue ProcessorIEO · Traditional | Innovative Medical Systems, Inc. | 12/29/1992SE |
| K883599 | LX-80 Automated Tissue Processor (Plastic)IEO · Traditional | Innovative Medical Systems, Inc. | 09/02/1988SE |
| K881165 | Sakura HEM-480 Electron Microscopy ProcessorIEO · Traditional | Sakura Finetek U.S.A., Inc. | 07/01/1988SE |
| K853938 | LX 300 Tissue ProcessorIEO · Traditional | Innovative Medical Systems, Inc. | 10/10/1985SE |
| K851054 | LX120 Tissue ProcessorIEO · Traditional | Innovative Medical Systems, Inc. | 05/15/1985SE |
| K843506 | LKB 2189 UltroprocessorIEO · Traditional | Lkb Instruments, Inc. | 11/30/1984SE |
| K834599 | Autotechnicon V Tissue Process SysIEO · Traditional | Technicon Instruments Corp. | 02/04/1984SE |
| K831313 | Tissue-Tek V.I.P. 100/200IEO · Traditional | Miles Laboratories, Inc. | 07/28/1983SE |
| K801513 | Tissue Processing SystemIEO · Traditional | Innovative Medical Systems, Inc. | 07/28/1980SE |
| K801427 | Tissue-Tek III Mini-Rapid ProcessorIEO · Traditional | Miles Laboratories, Inc. | 07/28/1980SE |
| K771308 | Tissue-Tek III V.I.P.IEO · Traditional | Miles Laboratories, Inc. | 08/22/1977SE |
| K761062 | Histo-Tek W/ Automatic CoverslipperIEO · Traditional | Miles Laboratories, Inc. | 03/07/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1683-2025 Class II | HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version:…There is a leakage issue associated with the tubing in the manifold of the instrument. | Leica Biosystems Melbourne Pty Ltd | 04/02/2025Open, Classified |
| Z-1947-2024 Class II | Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels… | Leica Biosystems Nussloch GmbH | 04/10/2024Open, Classified |
| Z-0590-2024 Class II | Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS… | Leica Biosystems Nussloch GmbH | 11/20/2023Open, Classified |
| Z-2660-2017 Class II | Nussloch GmbH ASP6025 Tissue ProcessorIncorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit. | Leica Microsystems, Inc. | 06/19/2017Open, Classified |
| Z-2779-2015 Class III | The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The…The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which… | Leica Microsystems, Inc. | 08/05/2015Terminated |
| Z-2804-2015 Class II | The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica…The ASP6025 Tissue Processor instrument is incorrectly getting into a state of bottle empty during retort… | Leica Microsystems, Inc. | 07/27/2015Terminated |
| Z-1815-2013 Class II | Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor…The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To… | Leica Microsystems, Inc. | 11/13/2012Terminated |
| Z-1473-2012 | ASP 6025 Vacuum Tissue Processor; an automated modular tissue processor; Leica…There is a potential malfunction with the device in autorotation mode, which can lead to incorrect reagent… | Leica Microsystems, Inc. | 03/30/2012Terminated |
| Z-2597-2011 | Peloris II Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly…The processor potentially has a faulty impellor which could lead to reagent carry-over from one processing… | Leica Microsystems, Inc. | 04/11/2011Terminated |
| Z-1551-2010 | Peloris Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149…Confusion during manually changing reagents, general users running unvalidated protocols, and wax valve… | Leica Microsystems, Inc. | 02/09/2010Terminated |
| Z-1320-2010 | ThermoFisher Scientific Microm STP 420D automated tissue processor.The firm has received complaints regarding specimen integrity (higher rate of specimen fragmentation) as… | Thermo Fisher Scientific | 06/03/2009Terminated |