The Binding Site Group, Ltd.: Medical Device Recall in 2021 - (Recall #: Z-0274-2022)

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:

Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S

Product Classification:

Class II

Date Initiated: October 15, 2021

Date Posted: December 1, 2021

Recall Number: Z-0274-2022

Event ID: 88921

Reason for Recall:

Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.

Status: Terminated

Product Quantity: 2,254 kits

Code Information:

Model Number: LK018.S UDI Code: 05051700006477 Lot Number: 472776 Model Number:LK018.10S UDI Code: 05051700012201 Lot Number: 472664

Distribution Pattern:

U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada

Voluntary or Mandated:

Voluntary: Firm initiated