The Binding Site Group, Ltd.: Medical Device Recall in 2017 - (Recall #: Z-1053-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases

Product Classification:

Class II

Date Initiated: October 28, 2016

Date Posted: January 25, 2017

Recall Number: Z-1053-2017

Event ID: 76050

Reason for Recall:

A change in the calibration curve causing an increase in false prozone flags.

Status: Terminated

Product Quantity: 3,088

Code Information:

Lot #400012, 400257

Distribution Pattern:

Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia.

Voluntary or Mandated:

Voluntary: Firm initiated