Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Randox RX Imola Analyser with ISE Recalled by Randox Laboratories Ltd. Due to An issue was identified where the software froze...

Date: April 28, 2021
Company: Randox Laboratories Ltd.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Randox Laboratories Ltd. directly.

Affected Products

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

Quantity: 50 kits

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Randox Laboratories Ltd.

Randox Laboratories Ltd. has 72 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report