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HistoCore PELORIS
LEICA BIOSYSTEMS MELBOURNE PTY LTD · Model Basket Spaced · UDI-DI 09349458004736
10
510(k) clearances
1,657
Adverse events
11
Recalls
31
Facilities
Description
Contain cassettes with specimens and are stacked into the retorts. Includes dividers to ensure cassettes are correctly spaced for optimal processing.
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 in the paraffin tan |
| 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 incorrect assignment of the |
| 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 correctly in the case of an |
| 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 prior to reaching leve |
| 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 case of a pressure f |
| 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 damage or to loss of t |
| 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 processing, leading to rebi |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.