Copan WASP is recalling all software versions of PhenoMATRIX, which is an AI-powered tool used to interpret bacterial culture plates. This recall affects 14 units that were distributed nationwide. The software is being recalled because it does not have required FDA clearance, and there is a potential risk that the colony counts or morphology information provided by the software may not accurately reflect the actual culture plate.
If the software provides inaccurate colony counts or morphology details, it could lead to an incorrect patient diagnosis and improper subsequent medical care. While no injuries or misdiagnoses have been reported, the accuracy of the tool has not been verified by the FDA for clinical use.
Recall Number: Z-1812-2025. Software used for bacterial culture plate interpretation and workup.
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.