Bionova® (K)PCD222-CRecalls & reported problems
Terragene S.A. · Steam Test Pack PCD Kit (25 test packs and 25 control BIs) · Class 2
All models of Bionova (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07798164676027), received between Dec 27, 2023 and Dec 27, 2023 — classified as 1 malfunction.
1 FDA recall record name this device's identifier, 1 still open.
1 other recall 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Dec 7, 2023Class IIOpen, 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 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.
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 ↗
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.
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- VERIFY LCB007Steris Corporation · Indicator, biological sterilization process1 recall0 reports
- VERIFY S3065Steris Corporation · Indicator, biological sterilization process1 recall0 reports
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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