HistoCore SPECTRA CV 000000014051454200Recalls & reported problems

Leica Biosystems Nussloch GmbH · The HistoCore SPECTRA CV is a fully automated coverslipper that is used to apply mounting media between the slide and coverglass. Then a coverglass is applied in order to preserve conserve the specimen and to create a uniform visual surface for microscopic research on histological and cytological tissue samples for medical diagnostics (e.g. cancer diagnostics). This instrument may be operated only in conjunction with the coverglasses and mounting media approved by Leica. · Class 1

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049188203953), received between Oct 30, 2020 and Jan 14, 2025 — classified as 1 injury, 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
Use of Device Problem1

Patient problems

Insufficient Information1
Laceration(s)1

Recent adverse event reports

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

MalfunctionJan 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2024 LEICA BIOSYSTEMS RECEIVED THE CONFIRMATION, THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE SPECTRA CV, MICROSCOPE SLIDE COVERSLIPPER. AS A RESULT, THE SAMPLES WERE DAMAGED, BUT NO NEW REBIOPSY WAS NECESSARY.
Patient problems: Insufficient Information
MAUDE report 21147756 ↗
InjuryOct 30, 2020Use of Device Problem; Use of Device Problem
ON 02 OCTOBER 2020, LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT A USER WAS INJURED WHILE ATTEMPTING TO CLEAN THE SHIFTER AND RAIL ON THEIR COVERSLIPPER, HISTOCORE SPECTRA CV. THE INJURED USER HAD PIECES OF GLASS IN HER FINGER AND VISITED THE EMERGENCY ROOM TO HAVE THE GLASS REMOVED AND THEN RETURNED TO WORK. NO STITCHES WERE REQUIRED. THE USER WAS IDENTIFIED AS A FEMALE IN HER 20'S.
Patient problems: Laceration(s)
MAUDE report 10762845 ↗

Device details

UDI-DI	`04049188203953`
Brand	HistoCore SPECTRA CV
Model	000000014051454200
Catalog no.	14051454200
Company	Leica Biosystems Nussloch GmbH
Product code	KPA · Slide stainer, automated
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 20, 2020

Device type (GMDN): Microscope slide coverslip IVD

A thin piece of glass or a plastic sheath placed over a specimen on a microscope slide, to serve as a physical barrier to protect the specimen from mechanical forces and environmental exposure. 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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