Copan WASP recalls PhenoMATRIX
Recalled Product
PhenoMATRIX
Hazard / Issue
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.
Issued by
FDA
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