The Binding Site Group, Ltd.: Medical Device Recall in 2021 - (Recall #: Z-0943-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 18, 2020

Date Posted: February 10, 2021

Recall Number: Z-0943-2021

Event ID: 86926

Reason for Recall:

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.

Status: Terminated

Product Quantity: 213 kits in the U.S.

Code Information:

Model Number: LK016.M.OPT.A UDI: 05051700019866 Lot Number: 454763

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated