BionovaRecalls & reported problems across all models
Terragene S.A. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Bionova model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 3 models of Bionova by Terragene S.A. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Dec 27, 2023 and Jun 21, 2024 — classified as 3 malfunctions.
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
Bionova 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.
- Dec 7, 2023Open, Classified
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Z-0837-2024 · Root cause: Labeling False and Misleading · Recall details · FDA record ↗
Most reported Bionova problems
Device problems
- Appropriate Device Problem Term/Code Not Available3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Bionova models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bionova® (K)PCD222-CIndicator, Biological Sterilization Process1 recall1 report
- Bionova® BT220Indicator, Biological Sterilization Process1 report
- Bionova® IC10/20FRLCDIndicator, Biological Sterilization Process1 report
Recent Bionova adverse event reports
The 3 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
FALSE NEGATIVE RESULT. NOT ENOUGH EVIDENCE FOR MISUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19590490 ↗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 ↗MalfunctionDec 27, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DURING A TRIAL, A BI USED INSIDE THE PCD TEST PACK GAVE A POSITIVE RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18399056 ↗
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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