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.
