Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PhenoMATRIX Recalled by Copan WASP Due to AI-powered bacterial culture plate interpretation and workup software...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Copan WASP directly.
Affected Products
PhenoMATRIX
Quantity: 14
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Copan WASP
Copan WASP has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report