BIOTRACERecalls & reported problems across all models
Terragene S.A. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one BIOTRACE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of BIOTRACE by Terragene S.A. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between May 30, 2025 and May 30, 2025 — classified as 1 malfunction.
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
BIOTRACE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 15, 2025Open, Classified
Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
Z-1248-2025 · Root cause: Labeling False and Misleading · Recall details · FDA record ↗
Most reported BIOTRACE problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
BIOTRACE models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BIOTRACE™ 73135Indicator, Biological Sterilization Process1 recall0 reports
- BIOTRACE™ 73400Indicator, Biological Sterilization Process1 report
Recent BIOTRACE adverse event reports
The 1 most recent reports across all models, 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 ↗
Other Terragene S.A. products
All Terragene S.A. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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