# FDA recall Z-1996-2025

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2025-05-07.

## Product

DxI 9000 Access Immunoassay Analyzer C11137

## Reason for recall

Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.

## Distribution

Worldwide - US Nationwide distribution in the states of AR, CA, FL, GA, HI, ID, IL, IN, KY, LA, ME, MI, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, WA, WI and the countries of Algeria, Australia, Austria, Belgium, Brazil, C¿te d'Ivoire, Croatia, Czechia, France, Germany, Hungary, India, Ireland, Israel, Italy, Kazakhstan, Korea, Republic of, Libya, New Zealand, Oman, Poland, Portugal, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom of Great Britain and Northern Ireland.

## Key facts

- **Recall number:** Z-1996-2025
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-07
- **Report date:** 2025-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chaska, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1996-2025

## Citation

> AI Analytics. FDA recall Z-1996-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1996-2025. Source: US FDA. Licensed CC0.

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