# FDA recall Z-2666-2023

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2023-08-08.

## Product

ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)

## Reason for recall

There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge.

## Distribution

US Nationwide. Global Distribution

## Key facts

- **Recall number:** Z-2666-2023
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-08
- **Report date:** 2023-10-11

- **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-2666-2023

## Citation

> AI Analytics. FDA recall Z-2666-2023. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-2666-2023. Source: US FDA. Licensed CC0.

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