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 Freelite Mx Kappa Free Kit REF LK016.M.OPT.A Recalled by The Binding Site Group, Ltd. Due to Due to customer complaints of positive bias impacting...

Date: November 18, 2020
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 Freelite Mx Kappa Free Kit REF LK016.M.OPT.A

Quantity: 213 kits in the U.S.

Why Was This Recalled?

Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.

Where Was This Sold?

This product was distributed to 10 states: CO, FL, IA, MA, NJ, NY, NC, OH, SD, UT

Affected (10 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