# FDA recall Z-2013-2021

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2021-04-28.

## Product

Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R

## Reason for recall

An issue was identified where the software froze during processing of commands, which resulted in no results displayed.

## Distribution

US Nationwide Distribution and Puerto Rico.

## Key facts

- **Recall number:** Z-2013-2021
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-28
- **Report date:** 2021-07-14
- **Termination date:** 2021-12-03

- **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-2013-2021

## Citation

> AI Analytics. FDA recall Z-2013-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2013-2021. Source: US FDA. Licensed CC0.

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