Tissue-Tek® Paraform® 7019Recalls & reported problems

Sakura Finetek U.S.A., Inc. · Biopsy Cassettes, 13 x 13 mm · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00615233080998), received between Dec 20, 2023 and Dec 20, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Improper or Incorrect Procedure or Method1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

InjuryDec 20, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
ON 19-DEC-2023 SAKURA FINETEK USA RECEIVED A NOTIFICATION FROM SAKURA FINETEK EUROPE THAT ON 11-DEC-2023, THE LOCAL APPLICATION SPECIALIST FROM SAKURA FINETEK BELGIUM WAS INFORMED THAT CUSTOMER AZ SINT-MAARTEN HAD LOST A TISSUE SAMPLE (OESOPHAGUS BIOPSY) DURING PROCESSING. THE SAMPLE WAS PLACED IN A TISSUE-TEK PARAFORM BIOPSY CASSETTE,13X13MM, WHICH SHOULD CONTAIN BLUE FOAM TO KEEP THE SAMPLE IN PLACE. HOWEVER, CUSTOMER NOTICED AFTER EMBEDDING THAT NO TISSUE WAS PRESENT IN THE CASSETTE AND THE BLUE FOAM WAS MISSING. NO OTHER TISSUE OF THE PATIENT WAS AVAILABLE. SAKURA FINETEK BELGIUM REQUESTED INFORMATION IF A RE-BIOPSY WAS NEEDED BUT THE CUSTOMER WAS NOT WILLING TO PURSUE THIS INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18369240 ↗

Device details

UDI-DI	`00615233080998`
Brand	Tissue-Tek® Paraform®
Model	7019
Company	Sakura Finetek U.S.A., 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	Nov 3, 2023

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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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.