The Binding Site Group, Ltd. recalls Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A

Recall date

November 18, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0943-2021

FDA classification

Class II

Brand / firm

The Binding Site Group, Ltd.

Sold / distributed

U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT. O.U.S.: Not provided

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A