Class 2 Device Recall PhenoMATRIX

• Date Initiated by Firm: May 06, 2025
• Date Posted: May 21, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1812-2025
• Recall Event ID: 96765
• Product Classification: Automated colony counter - Product Code KZB
• Product: PhenoMATRIX
• Code Information: All software versions
• Recalling Firm/ Manufacturer: Copan WASP; Via Achille Grandi, 32; Brescia Italy
• Manufacturer 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.
• FDA Determined Cause: No Marketing Application
• Action: 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
• Quantity in Commerce: 14
• Distribution: US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.