Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Liquid Immunoassay Premium Controls Recalled by Randox Laboratories Ltd. Due to The target value for uptake is incorrect on...

Date: February 7, 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

Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert

Quantity: 4

Why Was This Recalled?

The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.

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