# FDA recall Z-1280-2024

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2024-01-24.

## Product

Atellica IM Erythropoietin (EPO) Assay (100 Test)

## Reason for recall

Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference  interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.

## Distribution

Worldwide - US Nationwide distribution in the states of AL, CA, IA, IL, MI, MN, NC, NE, NV, NY, OH and TX; The countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, India, Italy, Japan, Latvia, Malaysia, Netherlands, Norway, P.R. China, Pakistan, Poland, Portugal, Republic of South Korea, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, U.A.E., United Kingdom.

## Key facts

- **Recall number:** Z-1280-2024
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-24
- **Report date:** 2024-03-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1280-2024

## Citation

> AI Analytics. FDA recall Z-1280-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1280-2024. Source: US FDA. Licensed CC0.

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