Home › Device types › IEO
Processor, Tissue, Automated
FDA product code IEO · Class 1 · Pathology
99
Registered devices
1,657
Adverse events
11
Recalls
12
510(k) clearances
Devices with this code
ASP6025 120V/50-60 Hz — Leica Biosystems Nussloch GmbHASP6025 S 230V/50-60Hz — Leica Biosystems Nussloch GmbHThermo Fisher — SHANDON DIAGNOSTICS LIMITEDThermo Fisher — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDLid — Leica Biosystems Nussloch GmbHThermo Fisher — SHANDON DIAGNOSTICS LIMITEDRetaining device P for wax station — Leica Biosystems Nussloch GmbHThermo Fisher — SHANDON DIAGNOSTICS LIMITEDExtraction tube — Leica Biosystems Nussloch GmbHEpredia — SHANDON DIAGNOSTICS LIMITEDTissue-Tek® — SAKURA FINETEK U.S.A., INC.Epredia — SHANDON DIAGNOSTICS LIMITEDEpredia — SHANDON DIAGNOSTICS LIMITEDHisto-Tek® VP1™ — SAKURA FINETEK U.S.A., INC.Thermo Fisher — SHANDON DIAGNOSTICS LIMITEDThermo Fisher — SHANDON DIAGNOSTICS LIMITEDSilicone Pad — Leica Biosystems Nussloch GmbHEpredia — SHANDON DIAGNOSTICS LIMITEDLeica TP1020 (Single loading) with vacuum/ without fume control — Leica Biosystems Nussloch GmbHPathTezt® — BIOCYTECH CORPORATION SDN. BHD.Leica TP1020 with Chloroform — Leica Biosystems Nussloch GmbHLeica ASP300 S - 230-240V — Leica Biosystems Nussloch GmbHBasket set Leica ASP300 S — Leica Biosystems Nussloch GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-02 | Leica Biosystems Melbourne Pty Ltd | There is a leakage issue associated with the tubing in the manifold of the instrument. |
| 2024-04-10 | LEICA BIOSYSTEMS NUSSLOCH GMBH | Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or |
| 2023-11-20 | LEICA BIOSYSTEMS NUSSLOCH GMBH | There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrec |
| 2017-06-19 | Leica Microsystems, Inc. | Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit. |
| 2015-08-05 | Leica Microsystems, Inc. | The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctl |
| 2015-07-27 | Leica Microsystems, Inc. | The ASP6025 Tissue Processor instrument is incorrectly getting into a state of bottle empty during retort filling, after passing the fill lever sensor 2 and pr |
| 2012-11-13 | Leica Microsystems, Inc. | The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use (RTU) bottles from other suppliers than Leica. In |
| 2012-03-30 | Leica Microsystems, Inc. | There is a potential malfunction with the device in autorotation mode, which can lead to incorrect reagent handling of the device. The end result may lead to da |
| 2011-04-11 | Leica Microsystems, Inc. | The processor potentially has a faulty impellor which could lead to reagent carry-over from one processing step to another, |
| 2010-02-09 | Leica Microsystems, Inc. | Confusion during manually changing reagents, general users running unvalidated protocols, and wax valve leakage have contributed to tissue damage during process |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.