# FDA recall Z-2455-2024

> **Beckman Coulter Mishima K.K.** · Class II · device recall initiated 2024-06-05.

## 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

There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved for calibration, after a calibration test has been placed and completed, the same rack may be used to place both a patient order and a calibration order. When a patient sample and a non-barcoded calibrator tube is processed on the rack, the calibration result will be reported as a patient result. Issue 2:  calibration with expired calibrator. They both may cause erroneous patient results, but the probability of serious adverse health consequences or death is unlikely.

## 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, and South Africa.

## Key facts

- **Recall number:** Z-2455-2024
- **Recalling firm:** Beckman Coulter Mishima K.K.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-05
- **Report date:** 2024-08-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2455-2024

## Citation

> AI Analytics. FDA recall Z-2455-2024. Retrieved 2026-08-03 from https://api.ai-analytics.org/recall/Z-2455-2024. Source: US FDA. Licensed CC0.

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