# FDA recall Z-0105-2023

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2022-09-19.

## Product

Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay

## Reason for recall

Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.

## Distribution

Worldwide distribution - US Nationwide.

## Key facts

- **Recall number:** Z-0105-2023
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-19
- **Report date:** 2022-10-26

- **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-0105-2023

## Citation

> AI Analytics. FDA recall Z-0105-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0105-2023. Source: US FDA. Licensed CC0.

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