Leica Biosystems 3800455Recalls & reported problems

Leica Biosystems Richmond, Inc. · PERMASLIDE Plus, White, Non-Clipped, Adhesive, · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20849832023153), received between Jun 25, 2025 and Jun 25, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1
Insufficient Device Problem Information1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 25, 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 29 MAY, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "WE JUST RECENTLY HAD SOME ISSUES WITH LIVERS, IT NOT A NORMAL THING BUT...TISSUE FALL OFF. WE OCCASIONALLY HAVE A SLIDE OR TWO ONCE A MONTH AT WORST. IN THIS CASE IT WAS CLOSER TO 20-30 SLIDES THAT WERE AFFECTED."ON 14 JUNE 2025, THE CUSTOMER ADVISED LEICA BIOSYSTEMS THAT THE TISSUE WAS NON-CLINICAL TISSUE AND ADDITIONAL TISSUE WAS AVAILABLE. NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER TO DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22333392 ↗

Device details

UDI-DI	`20849832023153`
Brand	Leica Biosystems
Model	3800455
Company	Leica Biosystems Richmond, Inc.
Product code	KEW · SLIDES, MICROSCOPE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 11, 2025

Device type (GMDN): General specimen microscopy slide IVD, single-use

A glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.

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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