Copan WASP recalls PhenoMATRIX

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.

PhenoMATRIX

On 5/6/2025, recall notices were mailed to customers informing them of the following: Ensure the plate images are reviewed against the actual agar plate to verify the assessment you performed by the digital image inspection. Complete and return the response form via email to regulatory.wasp@copangroup.com

• FDA enforcement recordOfficial FDA database entry for Z-1812-2025
• FDA device classification · KZBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.2170The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Copan WASPSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.