Home / Recalls / Copan WASP / Z-1812-2025

Z-1812-2025 Class II Ongoing

Recalled by Copan WASP — Brescia, N/A

Recall Details

Product Type: Devices
Report Date: May 28, 2025
Initiation Date: May 6, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14

Product Description

PhenoMATRIX

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 Pattern

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

Code Information

All software versions