# FDA recall Z-2089-2025

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2025-06-04.

## Product

ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)

## Reason for recall

Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

## Distribution

Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA, CL, CN, CO, CR, HK, ID, IN, JP, KR, MX, MY, PE, PY, SA, SG, TH, TW, UY, VN, & ZA.

## Key facts

- **Recall number:** Z-2089-2025
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-04
- **Report date:** 2025-07-09

- **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-2089-2025

## Citation

> AI Analytics. FDA recall Z-2089-2025. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-2089-2025. Source: US FDA. Licensed CC0.

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