Leica Biosystems 39LC-500-2-LRecalls & reported problems

Leica Biosystems Richmond, Inc. · IP ActivFlo Routine I, Taped, Blue · 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 20849832022378), received between Oct 22, 2025 and Oct 22, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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

Device Difficult to Setup or Prepare1

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, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
ON 25 SEPTEMBER 2025, LEICA BIOSYSTEMS RECEIVED A COMPLAINT DETAILING "THE PLASTIC SEEMS QUITE FLIMSY, AND STAFF HAVE HAD ISSUES WITH THEM CLOSING PROPERLY." ON 18 OCTOBER 2025, THE LEICA ACCOUNT MANAGER ADVISED THE LEICA ASSOCIATE, QUALITY ASSURANCE THAT THE AWARENESS DATE FOR THIS EVENT WAS 21 AUGUST 2025.
Patient problems: Insufficient Information
MAUDE report 23362929 ↗

Device details

UDI-DI	`20849832022378`
Brand	Leica Biosystems
Model	39LC-500-2-L
Company	Leica Biosystems Richmond, Inc.
Product code	IDZ · CASSETTES, TISSUE
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	Apr 23, 2025

Device type (GMDN): Histology tissue cassette IVD, laboratory processing, single-use

A small device intended to be used in the laboratory to support/contain clinical tissue specimens (e.g., biopsy samples) to facilitate specimen processing [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination, and storage. It is in the form of a plastic container, with or without a lid, with drainage holes to maximize fluid exposure during tissue submersion in a parent device into which the container is loaded. It may, in addition, include a fenestrated insert to hold and prevent the loss of a smaller specimens. This is a single-use device.

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All CASSETTES, TISSUE devices →

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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