PhenoMATRIX

FDA device recall Z-1812-2025 · posted 2025-05-21 · Open, Classified

Recall details

Recalling firm

Copan WASP

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.

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

Root cause

No Marketing Application

Status

Open, Classified

Product code

KZB

Quantity affected

14

Distribution

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

Date initiated

2025-05-06

Date posted

2025-05-21

Location

Brescia, Italy