PhenoMATRIX

This recall is currently active, issued May 21, 2025. It was issued by Copan Wasp Via Achille Grandi.

Company

Copan Wasp Via Achille Grandi

Recall Initiated

May 6, 2025

Posted

May 21, 2025

Recall Number

Z-1812-2025

Quantity

14

Official Source

View on FDA website ↗

Reason for Recall

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.

Distribution

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

Lot / Code Info

All software versions

Root Cause

No Marketing Application

Action Taken

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