# FDA recall Z-0599-2025

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2024-10-21.

## Product

Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma.  Siemens Material Number (SMN): 11097635

## Reason for recall

Potential for falsely depressed auto-diluted  results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH ¿2-Microglobulin (B2M) reagent.

## Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hungary, India, Iran, Israel, Italy, Ivory Coast, Japan, Jordan, Kuwait,  Mexico, Morocco, Oman, P.R. China, Pakistan, Paraguay, Poland, Portugal, Saudi Arabia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, U.A.E., Uganda, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zaire.

## Key facts

- **Recall number:** Z-0599-2025
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-21
- **Report date:** 2024-12-11

- **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-0599-2025

## Citation

> AI Analytics. FDA recall Z-0599-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0599-2025. Source: US FDA. Licensed CC0.

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