# FDA recall Z-2490-2019

> **Randox Laboratories Ltd.** · Class III · device recall initiated 2019-07-12.

## Product

This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.

## Reason for recall

Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).

## Distribution

Nationwide  Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,

## Key facts

- **Recall number:** Z-2490-2019
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-12
- **Report date:** 2019-09-18
- **Termination date:** 2020-06-17

- **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-2490-2019

## Citation

> AI Analytics. FDA recall Z-2490-2019. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2490-2019. Source: US FDA. Licensed CC0.

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