# FDA recall Z-0325-2024

> **Sentinel CH SpA** · Class II · device recall initiated 2023-09-29.

## Product

IRON assay, Reference Numbers 6K95-41 and 6K95-30

## Reason for recall

A high recovery of Iron assay has been observed at some customer sites.  Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument.     When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-0325-2024
- **Recalling firm:** Sentinel CH SpA
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-29
- **Report date:** 2023-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Milan, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0325-2024

## Citation

> AI Analytics. FDA recall Z-0325-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0325-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*