# FDA recall Z-0501-2024

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2023-10-11.

## Product

RANDOX Total Bilirubin.

## Reason for recall

Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.

## Distribution

US Nationwide distribution in the states of AR, GA, NC, TN, & PR.

## Key facts

- **Recall number:** Z-0501-2024
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-11
- **Report date:** 2023-12-13

- **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-0501-2024

## Citation

> AI Analytics. FDA recall Z-0501-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0501-2024. Source: US FDA. Licensed CC0.

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