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Copan WASP recalls PhenoMATRIX
Recalled May 28, 2025 · FDA recall Z-1812-2025 · 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. · FDA Class II
Units
14
Sold at
US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.
Description
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.
Product
PhenoMATRIX
Manufacturer(s)
Copan WASP
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →