BIOTRACE™ 73400Recalls & reported problems
Terragene S.A. · BIOTRACE™ Auto Read Pro Biological Indicator Reader. · Class 2
Data updated Oct 13, 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 07798375772471), received between May 30, 2025 and May 30, 2025 — 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
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.
MalfunctionMay 30, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE CUSTOMER REPORTS THAT THEIR READER COULD NOT REACH THE TEMPERATURE SELECTED. ADDITIONALLY, THE AUTO-READER GAVE OUT FALSE POSITIVE AND FALSE NEGATIVE RESULTS. THE CUSTOMER ALSO NOTES THAT THE TEMPERATURE UNIT IS BEING MISREPRESENTED, SHOWING CELSIUS INSTEAD OF FAHRENHEIT AND VICE VERSA. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENTS OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22119854 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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