# FDA recall Z-1794-2026

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2025-09-08.

## Product

MicroScan Neg Multidrug Resistant MIC 1 REF C32368  UDI-DI code: 15099590720568    Intended Use- For use with MicroScan Dried Gram Negative  MIC/Combo Panels and Dried Gram Negative Breakpoint Combo  Panels. MicroScan panels are designed for use in determining  antimicrobial agent susceptibility and/or identification to the species level  of aerobic and facultatively anaerobic gram-negative bacilli.

## Reason for recall

Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.

## Distribution

International distribution to the country of Poland.

## Key facts

- **Recall number:** Z-1794-2026
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-08
- **Report date:** 2026-04-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Sacramento, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1794-2026

## Citation

> AI Analytics. FDA recall Z-1794-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-1794-2026. Source: US FDA. Licensed CC0.

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