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 Series Mg - Product Usage: For the quantitative Recalled by Randox Laboratories Ltd. Due to Failing to meet the linearity performance claims quoted...

Date: November 13, 2020
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 Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326

Quantity: 4 kits

Why Was This Recalled?

Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine

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