Class II — Potential Health Hazard

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

Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Recalled by The Binding Site Group, Ltd. Due to Deterioration of C-reactive protein (CRP) reagent in Optilite...

Date: February 19, 2019
Company: The Binding Site Group, 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 The Binding Site Group, Ltd. directly.

Affected Products

Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser. The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.

Quantity: 10 kits

Why Was This Recalled?

Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About The Binding Site Group, Ltd.

The Binding Site Group, Ltd. has 28 total recalls tracked by RecallDetector.

Related Recalls

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