PhenoMATRIX — Class II medical device recall Z-1812-2025
Ongoing recall by Copan WASP, reported 2025-05-28, distributed nationwide. AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-
| Recall number | Z-1812-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Copan WASP, Brescia, N/A, Italy |
| Recall initiated | 2025-05-06 |
| Classified | 2025-05-21 |
| Reported by FDA | 2025-05-28 |
| Distributed | Nationwide (US) |
| Quantity | 14 |
| Reason classes | microbial contamination, software |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1812-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.