# FDA recall Z-0929-2022

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2022-02-09.

## Product

Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536

## Reason for recall

Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

## Distribution

Global Distribution.  US Nationwide.

## Key facts

- **Recall number:** Z-0929-2022
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-09
- **Report date:** 2022-04-20

- **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-0929-2022

## Citation

> AI Analytics. FDA recall Z-0929-2022. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0929-2022. Source: US FDA. Licensed CC0.

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