Bionova® BT220Recalls & reported problems
Terragene S.A. · Self-contained Biological Indicator for monitoring steam sterilization processes · 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 07798164670247), received between Jun 21, 2024 and Jun 21, 2024 — classified as 1 malfunction.
2 other recalls cover devices cleared under the same FDA submission (K163646); they may or may not involve this specific model.
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.
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 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K163646. One submission often covers many models, so check the product and lot details in each record.
- Z-1248-2025 · Jan 15, 2025 · Open, ClassifiedASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
- Z-0837-2024 · Dec 7, 2023 · Open, ClassifiedTerragene Bionova PCD (PCD222-C)
Other Indicator, Biological Sterilization Process devices
- VERIFY Dual SpeciesSteris Corporation · Indicator, biological sterilization process4 recalls1 report
- VERIFY S3069Steris Corporation · Indicator, biological sterilization process3 recalls0 reports
- Cyclesure 14324Advanced Sterilization Products Services Inc. · Indicator, biological sterilization process74 reports
- Celerity LCB044Steris Corporation · Indicator, biological sterilization process1 recall4 reports
- Celerity LCB053Steris Corporation · Indicator, biological sterilization process1 recall2 reports
- Celerity LCB049Steris Corporation · Indicator, biological sterilization process1 recall1 report
- Bionova® (K)PCD222-CTerragene S.A. · Indicator, Biological Sterilization Process1 recall1 report
- BIOlogical52 3702Hf Acquisition CO. LLC · Indicator, Biological Sterilization Process1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.