FDA-Device2025-05-28Class II
PhenoMATRIX
Copan WASP
Hazard
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.
Sold states
US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.
Affected count
14
Manufactured in
Via Achille Grandi, 32, N/A, Brescia, N/A, Italy
Products
PhenoMATRIX
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1812-2025Don't want to check this manually?
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