FDA Medical devices recall ·
PhenoMATRIX recall
- Recall number
- Z-1812-2025
- Date
- (initiated May 6, 2025)
- Company / brand
- Copan WASP
Via Achille Grandi, 32, Brescia, N/A, Italy - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 14
- Hazard tags
- Microbial contamination Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
PhenoMATRIX
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All software versions
Distribution
US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.
States: Arkansas California Illinois Kansas Massachusetts Maryland North Carolina New Jersey Nevada New York Pennsylvania Texas Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1812-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.