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 Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Recalled by Randox Laboratories Ltd. Due to An error in the assignment of the control...

Date: February 13, 2019
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 Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.

Quantity: 1 kit

Why Was This Recalled?

An error in the assignment of the control range pH in Blood Gas Control

Where Was This Sold?

This product was distributed to 1 state: WV

Affected (1 state)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