Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Cystatin C Calibrator - In vitro diagnostic (IVD) use in Recalled by Randox Laboratories Ltd. Due to Cystatin C Calibrator Series CVS 2699, is running...

Date: February 14, 2024
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

Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699

Quantity: 666 units

Why Was This Recalled?

Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods

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