Recall Z-1812-2025— Copan WASP
Class II · Ongoing
Class II FDA medical device recall by Copan WASP, initiated 2025-05-06. FDA's recall record names no specific 510(k) clearance for this event. Product: PhenoMATRIX. Reason: 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..
- Recalling firm
- Copan WASP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-05-06
- Firm location
- Brescia, N/A, Italy
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.