FDA Device recall Z-1812-2025
PhenoMATRIX
- FDA Device
- Class II
- ongoing
- Published 2025-05-28
On 2025-05-28 the FDA classified a Class II recall of PhenoMATRIX by Copan Wasp, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1812-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-06 |
| Published | 2025-05-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Copan Wasp |
| Distribution | US |
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.
Identifiers
| code_info | All software versions |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1812-2025%22
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