# FDA recall Z-1304-2024

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2024-02-07.

## Product

DCA Systems HbA1c Reagent Kit

## Reason for recall

The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be reported and potentially lead to incorrect patient management of glucose control. A positive bias may be observed with eleven HbA1c affected lots. Positive bias was observed when the performance of these five HbA1c lots was compared to NGSP pooled patient target-value assigned samples and the maximum bias observed was 19%.

## Distribution

Worldwide distribution - US Nationwide and the country of Taiwan.

## Key facts

- **Recall number:** Z-1304-2024
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-07
- **Report date:** 2024-03-27

- **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-1304-2024

## Citation

> AI Analytics. FDA recall Z-1304-2024. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1304-2024. Source: US FDA. Licensed CC0.

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