# FDA recall Z-1812-2025

> **Copan WASP** · Class II · device recall initiated 2025-05-06.

## 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.

## Distribution

US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.

## Key facts

- **Recall number:** Z-1812-2025
- **Recalling firm:** Copan WASP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-06
- **Report date:** 2025-05-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brescia, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1812-2025

## Citation

> AI Analytics. FDA recall Z-1812-2025. Retrieved 2026-08-01 from https://api.ai-analytics.org/recall/Z-1812-2025. Source: US FDA. Licensed CC0.

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