# FDA recall Z-1815-2025

> **Beckman Coulter Ireland, Inc.** · Class III · device recall initiated 2025-04-23.

## Product

Apo B Reagent, REF: OSR6143

## Reason for recall

The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.

## Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, MD, MI, NJ, NY, OH, OK, OR, PA, TX, VA, WA, WV and the countries of Argentina, Australia, Belarus, Belgium, Bulgaria, Canada, China, Czechia, Egypt, Estonia, France, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Netherlands, New Zealand, Russian Federation, Saudi Arabia, Slovakia, Spain, Switzerland, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland, United States of America, Viet Nam.

## Key facts

- **Recall number:** Z-1815-2025
- **Recalling firm:** Beckman Coulter Ireland, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-23
- **Report date:** 2025-06-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** O'Callaghan'S Mills, N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1815-2025

## Citation

> AI Analytics. FDA recall Z-1815-2025. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-1815-2025. Source: US FDA. Licensed CC0.

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