# FDA recall Z-2691-2024

> **Beckman Coulter Mishima K.K.** · Class II · device recall initiated 2024-07-10.

## Product

DxC 500 AU Clinical Chemistry Analyzer, REF C63520    is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

## Reason for recall

Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will be reported.  This issue may cause a delay of results.

## Distribution

Worldwide - U.S. Nationwide distribution in the states of AL, CA, GA, HI, IL, MI, MN, MS, NE, NY, OR, PA and SC. The countries of Lebanon, South Africa.

## Key facts

- **Recall number:** Z-2691-2024
- **Recalling firm:** Beckman Coulter Mishima K.K.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-10
- **Report date:** 2024-08-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunto-Gun, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2691-2024

## Citation

> AI Analytics. FDA recall Z-2691-2024. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-2691-2024. Source: US FDA. Licensed CC0.

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