FDA Recall: AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval

Company: Copan WASP
Date of Enforcement Report: 05/21/2025
Class II

PRODUCT

PhenoMATRIX

Recall Number:

Z-1812-2025

REASON:

AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and may lead to inaccurate counts and/or morphology characteristics impacting patient diagnosis and subsequent care.

RECALLING FIRM/MANUFACTURER:

Copan WASP

VOLUME:

14

DISTRIBUTION:

US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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