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Open, Classified

PhenoMATRIX

FDA Recall Z-1812-2025 · Posted 2025-05-21

Recalling FirmCopan WASP
Recall StatusOpen, Classified
Product CodeKZB
Date Initiated2025-05-06
Product Quantity14

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.

Firm 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 [email protected]

Root Cause

No Marketing Application

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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