# FDA recall Z-1233-2025

> **BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.** · Class II · device recall initiated 2025-01-10.

## Product

DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.

## Reason for recall

Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.

## Distribution

US: MA, CA, SC, LA, OK, GA, AL, TX, OR, ID, CO, MN, NY, MS, PA, WA, IL, MI, PR.  OUS: Lebanon, Poland, Ghana, Spain, South Africa, Slovakia, Ghana, Croatia, Seychelles, Australia, Republic of Korea

## Key facts

- **Recall number:** Z-1233-2025
- **Recalling firm:** BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-10
- **Report date:** 2025-03-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Suzhou, N/A, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1233-2025

## Citation

> AI Analytics. FDA recall Z-1233-2025. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-1233-2025. Source: US FDA. Licensed CC0.

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