Copan WASP recalls PhenoMATRIX

Recall date

May 6, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1812-2025

FDA classification

Class II

Brand / firm

Copan WASP

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PhenoMATRIX