# FDA recall Z-1759-2024

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2024-03-05.

## Product

Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.

## Reason for recall

Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.

## Distribution

Domestic: Nationwide Distribution.

## Key facts

- **Recall number:** Z-1759-2024
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-05
- **Report date:** 2024-05-15

- **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-1759-2024

## Citation

> AI Analytics. FDA recall Z-1759-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1759-2024. Source: US FDA. Licensed CC0.

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