# FDA recall Z-2425-2024

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2024-06-07.

## Product

RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers.    Catalogue Number: CYS4004

## Reason for recall

Cystatin C Reagent marketed without a 510 (k)

## Distribution

US Nationwide distribution in the states of AL, CA, GA, NY.

## Key facts

- **Recall number:** Z-2425-2024
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-07
- **Report date:** 2024-07-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin (North), Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2425-2024

## Citation

> AI Analytics. FDA recall Z-2425-2024. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/Z-2425-2024. Source: US FDA. Licensed CC0.

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