# FDA recall Z-0753-2024

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2023-11-20.

## Product

Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays  Catalog Number: CAL2351

## Reason for recall

Target for Alkaline Phosphatase (ALP) for the AMP  optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples

## Distribution

US Nationwide including Puerto Rico.

## Key facts

- **Recall number:** Z-0753-2024
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-20
- **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-0753-2024

## Citation

> AI Analytics. FDA recall Z-0753-2024. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0753-2024. Source: US FDA. Licensed CC0.

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