Class II — Potential Health Hazard

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

CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination Recalled by Randox Laboratories Due to The Antibody (R2 reagent) is showing a positive...

Date: February 1, 2023
Company: Randox Laboratories
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 directly.

Affected Products

CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826

Quantity: 2 kits

Why Was This Recalled?

The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range

Where Was This Sold?

This product was distributed to 3 states: OH, PA, WV

Affected (3 states)Not affected

About Randox Laboratories

Randox Laboratories has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report