Leica Biosystems 3800200AERecalls & reported problems

Leica Biosystems Richmond, Inc. · X-tra Adhesive Microscope 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 20849832025492), received between Jan 8, 2026 and Apr 2, 2026 — 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

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

Most reported problems

Device problems

Insufficient Device Problem Information3
Adverse Event Without Identified Device or Use Problem2

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.

MalfunctionApr 2, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ON (B)(6) 2026, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS AND REPORTED "SLIDES ARE NOT CHARGED. THEY ARE SAYING RISK OF TISSUE LOSS. SOME CHARGED SOME UNCHARGED."
Patient problems: Insufficient Information
MAUDE report 24770926 ↗
MalfunctionJan 21, 2026Insufficient Device Problem Information
ON 05 DECEMBER 2025, A COMPLAINT WAS RAISED WITH THE FOLLOWING INFORMATION: "THE TISSUE DO NOT STICK TO THE SLIDES". ON (B)(6) 2025, THE LEICA SENIOR APPLICATIONS CONSULTANT ADVISED THAT THERE WAS ADDITIONAL TISSUE AVAILABLE FOR RE-STAINING AND NO PATIENT REQUIRED A RE-BIOPSY AS A RESULT OF THIS EVENT. ON 26 DECEMBER 2025, THE LEICA SENIOR APPLICATIONS CONSULTANT ADVISED THE LEICA ASSOCIATE, QUALITY ASSURANCE THAT THE AWARENESS DATE FOR THIS EVENT WAS 24 OCTOBER 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24139751 ↗
MalfunctionJan 8, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ON (B)(6) 2025, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS AND REPORTED "WITH CERTAIN ANTIBODIES: ON (B)(6), P16, CYCLIN, INHIBIN, ER, PR, C-ERB, BETA CATENIN, KI67, THE TISSUE FLOATS OFF THE LEICA X-TRA SLIDES." NO ADVERSE IMPACT TO A PATIENT HAS BEEN REPORTED TO THE MANUFACTURER TO DATE.
Patient problems: Insufficient Information
MAUDE report 24014595 ↗

Device details

UDI-DI	`20849832025492`
Brand	Leica Biosystems
Model	3800200AE
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	Dec 13, 2024

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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