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 CHOL-cholesterol (total) test system intended to measure cholesterol in Recalled by Randox Laboratories Ltd. Due to When calibrating using the standard provided in the...

Date: November 1, 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 CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200

Quantity: 15 kits

Why Was This Recalled?

When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range

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