Leica Biosystems 000000000003800014Recalls & reported problems
Leica Biosystems Richmond, Inc. · Permaflex Plus Slides, White · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20849832023146), received between May 1, 2025 and Aug 13, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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
- Insufficient Device Problem Information3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ON 16 JULY 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "TECH HAD ISSUES PICKING UP THE TISSUE IN THEIR WATERBATH. TISSUE WOULD NOT STICK TO SLIDE. CUSTOMER THEN SWITCHED TO DIFFERENT SLIDE AND THEN WORKED FINE." AS OF 13 AUGUST 2025, LEICA BIOSYSTEMS HAS NOT RECEIVED INFORMATION AS TO EITHER THE FINAL STATUS OF THE PATIENT TISSUE SAMPLES INVOLVED IN THIS EVENT OR THE PATIENT IMPACT/OUTCOME. NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER TO DATE.
Patient problems: Insufficient Information
MAUDE report 22800226 ↗MalfunctionAug 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ON 16 JULY 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "CUSTOMER WAS HAVING ISSUES WITH TISSUE FALL OFF WITH STANDARD H&E." AS OF 13 AUGUST 2025, LEICA BIOSYSTEMS HAS NOT RECEIVED INFORMATION AS TO EITHER THE FINAL STATUS OF THE PATIENT TISSUE SAMPLES INVOLVED IN THIS EVENT OR THE PATIENT IMPACT/OUTCOME. NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER TO DATE.
Patient problems: Insufficient Information
MAUDE report 22800219 ↗MalfunctionMay 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ON 03 APRIL 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "TISSUE IS FALLING OFF THE SLIDES; 2ND SECTION FALLS OFF, OVEN IS USED 30 MIN, AFFECTS ONLY IHC, NOT ALL SECTIONS FALL OFF. NO IRRETRIEVABLE TISSUE LOSS WAS REPORTED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21947197 ↗
Other SLIDES, MICROSCOPE devices
- Leica Biosystems 3800200AELeica Biosystems Richmond, Inc. · SLIDES, MICROSCOPE3 reports
- Leica Biosystems 3800040Leica Biosystems Richmond, Inc. · SLIDES, MICROSCOPE2 reports
- Leica Biosystems 3800080ELeica Biosystems Richmond, Inc. · SLIDES, MICROSCOPE1 report
- Leica Biosystems S21.2113.ALeica Biosystems Richmond, Inc. · SLIDES, MICROSCOPE1 report
- Leica Biosystems 3800455Leica Biosystems Richmond, Inc. · SLIDES, MICROSCOPE1 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.
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