Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Optilite IgG4 Kit Product Code: LK009.OPT.A Recalled by The Binding Site Group, Ltd. Due to A change to the lower end of the...

Date: December 23, 2016
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 IgG4 Kit Product Code: LK009.OPT.A

Quantity: 9 users

Why Was This Recalled?

A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert

Where Was This Sold?

This product was distributed to 8 states: CA, CT, FL, MA, MI, PA, TX, WA

Affected (8 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