Class II — Potential Health Hazard

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

RX Imola (RX4900) For Professional Use for the quantitative in Recalled by Randox Laboratories Due to Abnormal premature termination of the software could affect...

Date: May 4, 2018
Company: Randox Laboratories
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 directly.

Affected Products

RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.

Quantity: 41 analyzers

Why Was This Recalled?

Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.

Where Was This Sold?

US Distribution including Puerto Rico and the state of : West Virginia.

About Randox Laboratories

Randox Laboratories has 6 total recalls tracked by RecallDetector.

Related Recalls

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