# FDA recall Z-1672-2025

> **Beckman Coulter Inc.** · Class II · device recall initiated 2025-03-17.

## Product

DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes:  C63519 / 14987666545058  C63520 / 14987666545065    Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3    The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer 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

The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.

## Distribution

Worldwide - U.S. Nationwide distribution including in the states of AL, CA, CO, GA, ID, IL, IN, LA, MA, MI,MN, MS, MT, NC, NM, NV, NY, OK, OR, PA, PR, SC, TN, TX, WA, and WI. The countries of Australia, Belgium, Bosnia and Herzegovina, Canada, Chile, Croatia, Egypt, Ethiopia, France, Georgia, Germany, Ghana, India, Italy, Korea, Lebanon, Libya, Malaysia, Netherlands, North Macedonia, Oman, Paraguay, Philippines, Poland, Puerto Rico, Qatar, Saudi Arabia, Seychelles, Slovakia, South Africa, Spain, Switzerland, and Tunisia.

## Key facts

- **Recall number:** Z-1672-2025
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-17
- **Report date:** 2025-05-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1672-2025

## Citation

> AI Analytics. FDA recall Z-1672-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1672-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*