# FDA recall Z-0328-2022

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2021-11-01.

## Product

RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum  REF: CH200

## Reason for recall

When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range

## Distribution

US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.

## Key facts

- **Recall number:** Z-0328-2022
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-01
- **Report date:** 2021-12-08
- **Termination date:** 2023-03-09

- **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-0328-2022

## Citation

> AI Analytics. FDA recall Z-0328-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0328-2022. Source: US FDA. Licensed CC0.

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