Leica Biosystems 3800040Recalls & reported problems

Leica Biosystems Richmond, Inc. · Apex BOND Superior Adhesive Slides · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20849832016438), received between Jan 21, 2026 and Jul 31, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Insufficient Device Problem Information2
Adverse Event Without Identified Device or Use Problem1

Patient problems

Insufficient Information1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 31, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50094506 ↗
MalfunctionJan 21, 2026Insufficient Device Problem Information
ON 21 NOVEMBER 2025, A COMPLAINT WAS RAISED WITH THE FOLLOWING INFORMATION "CUSTOMER USED APEX BOND FOR IHC STAINING ON BOND III AND BOND PRIME AND NOTICED THAT OFTEN TISSUE FLOATS AWAY, THE SWITCHED TO XTRA WITH MUCH BETTER PERFORMANCE."ON 15 DECEMBER 2025, THE LEICA ACCOUNT MANAGER ADVISED THE LEICA ASSOCIATE, QUALITY ASSURANCE THAT THE AWARENESS DATE FOR THIS EVENT WAS 30 OCTOBER 2025.
Patient problems: Insufficient Information
MAUDE report 24139693 ↗

Device details

UDI-DI	`20849832016438`
Brand	Leica Biosystems
Model	3800040
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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