Tuttnauer® WTL198-0057Recalls & reported problems

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

All models of Tuttnauer (3)

Data updated Oct 16, 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 07798164677475), received between Jan 9, 2024 and Jan 9, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE USER REPORTED THAT POSITIVE CONTROL BIS WERE SHOWING NEGATIVE RESULTS FOR THE FLUORESCENCE READOUT. NO FURTHER INFORMATION WAS SHARED BY THE USER OR THE DISTRIBUTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18475643 ↗

Device details

UDI-DI	`07798164677475`
Brand	Tuttnauer®
Model	WTL198-0057
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	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 20, 2022

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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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