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BIOTRACE™ 73135Recalls & reported problems

Terragene S.A. · BIOTRACE™ Auto Read 60 Steam BI Process Challenge Device · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. 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 · FDA record ↗

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-0837-2024 · Dec 7, 2023 · Open, Classified
    Terragene Bionova PCD (PCD222-C)

Other Indicator, Biological Sterilization Process devices

All Indicator, Biological Sterilization Process devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.