Bionova® IC10/20FRLCDRecalls & reported problems

Terragene S.A. · Auto-Reader Incubator for biological indicators · Class 2

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 07798164676706), received between Jun 10, 2024 and Jun 10, 2024 — classified as 1 malfunction.

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

Appropriate Device Problem Term/Code Not Available1

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.

MalfunctionJun 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A USER INFORMED THAT THE AUTO-READER GAVE OUT FALSE NEGATIVE RESULTS. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENTS OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19504688 ↗

Device details

UDI-DI	`07798164676706`
Brand	Bionova®
Model	IC10/20FRLCD
Company	Terragene S.A.
Product code	FRC · Indicator, Biological Sterilization Process
Class	Class 2
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	Feb 6, 2025

Device type (GMDN): Biological sterilization indicator reader

A mains electricity (AC-powered) device designed to accept a biological sterilization indicator (bacterial spores) and to rapidly indicate whether adequate sterilization conditions have been achieved by testing the resistance of the biological indicator previously exposed to a sterilization process (e.g., by steam, or chemical sterilization). It is a bench-top unit intended to provide suitable incubation conditions for the biological indicator and to detect fluorescent enzymatic signals that correlate with the resistance of the biological indicator.

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