# FDA recall Z-1424-2022

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2022-06-22.

## Product

Randox Cholesterol-  For the quantitative in vitro determination of Cholesterol in serum and plasma.  Catalog Number: CH2O0

## Reason for recall

Product fails to meet the performance claims quoted on the kit insert: Manual Procedure 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; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.

## Distribution

Nationwide Distribution - MD, OR, PR, MT, WV

## Key facts

- **Recall number:** Z-1424-2022
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-06-22
- **Report date:** 2022-07-27
- **Termination date:** 2024-05-10

- **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-1424-2022

## Citation

> AI Analytics. FDA recall Z-1424-2022. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-1424-2022. Source: US FDA. Licensed CC0.

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