Copan WASP: Device Recall
Recall #Z-1812-2025 · 05/06/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1812-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Copan WASP
- Status
- Ongoing
- Date Initiated
- 05/06/2025
- Location
- Brescia, N/A, Italy
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14
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.
Product Description
PhenoMATRIX
Distribution Pattern
US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.