# FDA recall Z-0751-2024

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2023-11-13.

## Product

Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)

## Reason for recall

There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum  Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the  IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed  Multi-Sera Level 3 (HE 1532) for Lipase target value.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0751-2024
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-13
- **Report date:** 2024-01-24

- **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-0751-2024

## Citation

> AI Analytics. FDA recall Z-0751-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0751-2024. Source: US FDA. Licensed CC0.

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