# FDA recall Z-0199-2024

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2023-09-06.

## Product

RX Daytona Plus (without ISE)-	IVD Clinical Chemistry Analyser  (1) RX4041, (2) RX4041R (refurbished)

## Reason for recall

RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting  sample re-run conditions when samples are above or below assay range and may result i  issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.

## Distribution

US Nationwide distribution including Puerto Rico

## Key facts

- **Recall number:** Z-0199-2024
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-06
- **Report date:** 2023-11-08

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0199-2024

## Citation

> AI Analytics. FDA recall Z-0199-2024. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0199-2024. Source: US FDA. Licensed CC0.

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