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 Liquid Assayed Specific Protein Control - Level 2 (SP Control 2) Recalled by Randox Laboratories Ltd. Due to The recalling firm has confirmed that Free Kappa...

Date: May 22, 2018
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 Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683

Why Was This Recalled?

The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains results, which are used as an aid in diagnosis of monoclonal gammopathy of undetermined significance and for Multiple Myeloma through review of the ratio with free lambda chains.

Where Was This Sold?

This product was distributed to 5 states: CA, IN, KS, ME, WV

Affected (5 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