# FDA recall Z-1249-2025

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2025-02-03.

## Product

Access Erythropoietin (EPO), Catalog Number - A16364  a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis)  in mammals. Renal production of EPO is regulated by changes in oxygen  availability. Under conditions of hypoxia, the level of EPO in the circulation  increases and this leads to increased production of red blood cells.

## Reason for recall

Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the affected lot may demonstrate repeatable falsely decreased results, which may lead to improper diagnosis or repeat testing.

## Distribution

Domestic distribution to AL AR AZ CA CT FL ID IL IN KS MA MI NC NE NJ NY OH OR PA TN TX UT WA WV. International distribution to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Korea, Republic of, Netherlands, Philippines, Russian Federation, Saudi Arabia, Slovakia, Spain, United Kingdom of Great Britain and Northern Ireland

## Key facts

- **Recall number:** Z-1249-2025
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-03
- **Report date:** 2025-03-12

- **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-1249-2025

## Citation

> AI Analytics. FDA recall Z-1249-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1249-2025. Source: US FDA. Licensed CC0.

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