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HistoCore PELORIS
LEICA BIOSYSTEMS MELBOURNE PTY LTD · Model HistoCore PELORIS 3 Win10/I-Scan Upgrade Kit · UDI-DI 09349458005573
10
510(k) clearances
1,657
Adverse events
11
Recalls
31
Facilities
Description
HistoCore PELORIS 3 Win10/I-Scan Upgrade Kit
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.