ASP6025 S 230V/50-60Hz 000000014049559058Recalls & reported problems
Leica Biosystems Nussloch GmbH · The ASP6025 S Tissue Processor is a modular tissue processor for the following laboratory applications: • Fixation • Dehydration • Infiltration with intermedium • Paraffin infiltration of histological tissue specimens. The ASP6025 S can be used as medical IVD product. The improved features of the ASP6025 S are the combination of: • Reduced processing time • Easier reagent exchange • Monitoring the ethanol quality by density measurement as well as the • Ability to replace xylene, a substance that is hazardous (including to the health), with special process protocols. The instrument has been designed so that it is safe to use by the operator as well as for processing specimens. However, the prerequisite for this is that it is operated according to these Instructions for Use. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049188210777), received between Mar 31, 2023 and Mar 31, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Tissue Breakdown1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 31, 2023Use of Device Problem; Use of Device Problem
ON 18 JANUARY 2023 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR ASP6025 S. ON (B)(6) 2023 THE CUSTOMER INFORMED LEICA BIOSYSTEMS, THAT AS A RESULT, 1 TISSUE SAMPLES HAS NOT BEEN DIAGNOSED, AND THE PATIENT HAS BEEN REBIOPSIED. THE AGE AND GENDER OF THE PATIENT IS 81, F.
Patient problems: Tissue Breakdown
MAUDE report 16654381 ↗
Other PROCESSOR, TISSUE, AUTOMATED devices
- HistoCore PELORIS HistoCore PELORIS 3 (100-120V)Leica Biosystems Melbourne Pty Ltd · Processor, Tissue, Automated1 recall28 reports
- HistoCore PEGASUS 000000014048858005Leica Biosystems Nussloch GmbH · PROCESSOR, TISSUE, AUTOMATED1 recall14 reports
- ASP6025 230V/50-60 Hz 000000014049543267Leica Biosystems Nussloch GmbH · PROCESSOR, TISSUE, AUTOMATED10 reports
- HistoCore PEGASUS Plus 000000014048858007Leica Biosystems Nussloch GmbH · PROCESSOR, TISSUE, AUTOMATED9 reports
- Leica ASP300 S - 230-240V 000000014047643514Leica Biosystems Nussloch GmbH · PROCESSOR, TISSUE, AUTOMATED5 reports
- Leica TP1020 VF/accessories 1491020US02Leica Biosystems Nussloch GmbH · PROCESSOR, TISSUE, AUTOMATED4 reports
- HistoCore PEARL 000000014049350667Leica Biosystems Nussloch GmbH · PROCESSOR, TISSUE, AUTOMATED4 reports
- Tissue-Tek VIP® 6 6040Sakura Finetek U.S.A., Inc. · PROCESSOR, TISSUE, AUTOMATED2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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