TERRAGENE S.A. has recalled 914 ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Devices (REF 73135) because the instructions for use contain a critical error. The instructions incorrectly state that the device should be incubated for 20 minutes, when the correct required time is 60 minutes. This discrepancy can lead to false results when monitoring sterilization processes. No injuries or incidents have been reported to date.
If the device is incubated for only 20 minutes instead of the required 60, it may fail to show that sterilization was unsuccessful. This creates a risk that medical instruments could be used on patients despite not being properly sterilized, potentially leading to healthcare-acquired infections.
Contains IFU Rev.A R0.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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