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 Total Bilirubin. Recalled by Randox Laboratories Ltd. Due to Randox has had reports of elevated patient results...

Date: October 11, 2023
Company: Randox Laboratories Ltd.
Status: Ongoing
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 Total Bilirubin.

Quantity: 1644 units

Why Was This Recalled?

Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.

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