# FDA recall Z-2027-2025

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2025-05-22.

## Product

Product: Atellica CH Diluent - CONS 2 x 1.5L;  Siemens Material Number (SMN): 11099300;

## Reason for recall

Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.

## Key facts

- **Recall number:** Z-2027-2025
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-22
- **Report date:** 2025-07-02

- **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-2027-2025

## Citation

> AI Analytics. FDA recall Z-2027-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2027-2025. Source: US FDA. Licensed CC0.

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