ASP6025 S 120V/50-60Hz 000000014049559068Recalls & 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 04049188210784), received between Sep 11, 2025 and Sep 11, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Device Ingredient or Reagent 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.
Reports received per month
Most reported problems
Device problems
- Device Ingredient or Reagent Problem1
Patient problems
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
ON (B)(6), A CUSTOMER NOTIFIED LEICA BIOSYSTEMS THAT THEIR "ROTINA NOTURNA" PROCESSING PROTOCOL, WHICH BEGAN ON (B)(6) AND ENDED AT 10:16 AM ON (B)(6), PRESENTED A QUALITY DEVIATION. PRIOR AND SUBSEQUENT PROCESSING DID NOT PRESENT ANY ISSUES. THE TISSUE SAMPLES PROCESSED IN THE AFFECTED RUN WERE ALL LARGE TISSUE SAMPLES. ON (B)(6), LEICA BIOSYSTEMS NUSSLOCH GMBH WAS INFORMED THAT ONE TISSUE SAMPLE COULD NOT BE DIAGNOSED, REQUIRING THE PATIENT CONCERNED TO UNDERGO A RE-BIOPSY.
Patient problems: Unspecified Tissue Injury
MAUDE report 23023743 ↗
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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