Leica Biosystems S21.2113.ARecalls & reported problems

Leica Biosystems Richmond, Inc. · BOND Plus Slides · 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 20849832023108), received between Oct 22, 2025 and Oct 22, 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

Insufficient Device Problem Information1

Patient problems

Insufficient Information1

Recent adverse event reports

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

MalfunctionOct 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ON 24 SEPTEMBER 2025, LEICA BIOSYSTEMS RECEIVED A COMPLAINT DETAILING "SECTION DROPPING OFF FROM THE SLIDE". ON 30 SEPTEMBER 2025, THE LEICA BIOSYSTEMS CUSTOMER SERVICE EXECUTIVE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION "¿THE ISSUE IS SECTIONS FALLING OFF THEIR BOND PLUS SLIDE". AS OF 22 OCTOBER 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. ALTHOUGH THE INFORMATION AVAILABLE INDICATES THAT THERE HAS BEEN NO ADVERSE IMPACT REPORTED TO THE MANUFACTURER IN ASSOCIATION WITH THE CIRCUMSTANCES INVOLVED IN THIS COMPLAINT, THE CIRCUMSTANCES INVOLVED IN THIS COMPLAINT HAVE PREVIOUSLY RESULTED IN SERIOUS INJURY AND ARE CONSIDERED A MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 23362817 ↗

Device details

UDI-DI	`20849832023108`
Brand	Leica Biosystems
Model	S21.2113.A
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	Jun 12, 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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