ASP6025 230V/50-60 Hz 000000014049543267Recalls & reported problems
Leica Biosystems Nussloch GmbH · The ASP6025 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 can be used as medical IVD product. The improved features of the ASP6025 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
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04049188158819), received between Feb 12, 2021 and Dec 8, 2023 — classified as 10 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (8 reports).
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
- Use of Device Problem8
- Therapeutic or Diagnostic Output Failure4
- Defective Component1
- Defective Device1
- Insufficient Device Problem Information1
- Material Deformation1
- Unexpected Therapeutic Results1
Patient problems
- Tissue Breakdown7
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryDec 8, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
ON (B)(6) 2023 LEICA BIOSYSTEMS RECEIVED THE CONFIRMATION, THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR ASP6025, TISSUE PROCESSOR. AS A RESULT THE TISSUE WAS UNDIAGNOSABLE, AND A REBIOPSY FOR 9 PATIENTS WAS RECOMMENDED.
Patient problems: Insufficient Information
MAUDE report 18289924 ↗InjuryOct 20, 2023Use of Device Problem; Use of Device Problem
ON (B)(6) 2023 LEICA BIOSYSTEMS RECEIVED THE COMPLAINT CONFIRMATION, THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR LEICA ASP6025 LEADING TO THE TISSUE DAMAGE. THE AFFECTED TISSUES WERE BEING BRITTLE AS WELL AS SHOWING POOR NUCLEAR DETAIL. ON (B)(6) 2023 LEICA BIOSYSTEMS RECEIVED FINAL CONFIRMATION THAT 9 PATIENT SAMPLES COULD NOT BE SUCCESSFULLY DIAGNOSED AND A RE-BIOPSY OF THE PATIENTS CONCERNED WILL THEREFORE BE REQUIRED.
Patient problems: Insufficient Information
MAUDE report 17974042 ↗InjuryAug 18, 2023Use of Device Problem; Use of Device Problem
ON (B)(6) 2023 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR ASP6025, TISSUE PROCESSOR. AS A RESULT, 6 TISSUE SAMPLES HAVE NOT BEEN DIAGNOSED.
Patient problems: Tissue Breakdown
MAUDE report 17571555 ↗InjuryMay 26, 2023Use of Device Problem; Use of Device Problem
ON (B)(6) 2023 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR ASP6025, TISSUE PROCESSOR. ON (B)(6) 2023 THE CUSTOMER INFORMED LEICA BIOSYSTEMS, THAT AS A RESULT, 5 TISSUE SAMPLES HAVE NOT BEEN DIAGNOSED.
Patient problems: Tissue Breakdown
MAUDE report 17009254 ↗InjuryMay 4, 2022Material Deformation; Therapeutic or Diagnostic Output Failure; Material Deformation
ON 05 APRIL 2022, A CUSTOMER REPORTED TO LEICA BIOSYSTEMS THAT ON (B)(6) 2022 THEY EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR ASP6025. AS A RESULT THE TISSUE WAS UNDIAGNOSABLE, AND A REBIOPSY FOR 3 PATIENTS WAS RECOMMENDED.
Patient problems: Tissue Breakdown
MAUDE report 14276487 ↗InjuryAug 18, 2021Unexpected Therapeutic Results; Use of Device Problem; Use of Device Problem
ON 02 AUGUST 2021 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED DAMAGED TISSUE SAMPLES DURING PROCESSING ON THEIR ASP6025. AS A RESULT 3 TISSUE SAMPLES HAVE NOT BEEN DIAGNOSED.
Patient problems: Tissue Breakdown
MAUDE report 12335207 ↗InjuryJul 19, 2021Use of Device Problem; Defective Device; Therapeutic or Diagnostic Output Failure; Use of Device Problem
ON 21 JUNE 2021 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED DAMAGED TISSUE SAMPLES DURING PROCESSING ON THEIR ASP6025. AS A RESULT 1 TISSUE SAMPLE FROM ONE PATIENT HAS NOT BEEN DIAGNOSED.
Patient problems: Tissue Breakdown
MAUDE report 12189750 ↗InjuryMay 5, 2021Use of Device Problem; Therapeutic or Diagnostic Output Failure; Use of Device Problem
ON (B)(6) 2021 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED DAMAGED TISSUE SAMPLES DURING PROCESSING ON THEIR ASP6025. AS A RESULT 2 TISSUE SAMPLES HAVE NOT BEEN DIAGNOSED; 1 TISSUE SAMPLE BELONGING TO A FEMALE PATIENT AND 1 TISSUE SAMPLE BELONGING TO A MALE PATIENT. THE 1 MALE PATIENT TISSUE SAMPLE COULD NOT BE DIAGNOSED.
Patient problems: Tissue Breakdown
MAUDE report 11778677 ↗InjuryMay 5, 2021Use of Device Problem; Therapeutic or Diagnostic Output Failure; Use of Device Problem
ON (B)(6) 2021 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED DAMAGED TISSUE SAMPLES DURING PROCESSING ON THEIR ASP6025. AS A RESULT 2 TISSUE SAMPLES HAVE NOT BEEN DIAGNOSED; 1 TISSUE SAMPLE BELONGING TO A FEMALE PATIENT AND 1 TISSUE SAMPLE BELONGING TO A MALE PATIENT. THE 1 FEMALE PATIENT HAS TO BE REBIOPSIED.
Patient problems: Tissue Breakdown
MAUDE report 11778666 ↗InjuryFeb 12, 2021Defective Component; Defective Component
ON (B)(6) 2021 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED DAMAGED TISSUE SAMPLES DURING PROCESSING ON THEIR ASP6025. AS A RESULT 3 TISSUE SAMPLES HAVE NOT BEEN DIAGNOSED, AND ON (B)(6) 2021 THE CUSTOMER INFORMED LEICA BIOSYSTEMS, THAT 3 PATIENTS HAVE TO BE REBIOPSIED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11320133 ↗
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
- 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
- ASP6025 S 230V/50-60Hz 000000014049559058Leica Biosystems Nussloch GmbH · PROCESSOR, TISSUE, AUTOMATED1 report
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.
How reports and recalls are matched · Editorial policy · Report an error on this page