The Binding Site Group, Ltd.: Medical Device Recall in 2017 - (Recall #: Z-1050-2017)

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:

Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.

Product Classification:

Class II

Date Initiated: November 28, 2012

Date Posted: January 25, 2017

Recall Number: Z-1050-2017

Event ID: 76049

Reason for Recall:

Calibration curve activity has increased over time in the kit lots listed.

Status: Terminated

Product Quantity: 1,002

Code Information:

Lot #323278, 327963

Distribution Pattern:

U.S. distribution to the following; CA, TX, HI, GA, PA, UT, NY, OK, ID, MA, AZ. Foreign distribution to the following; Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand, Taiwan, Belgium, France, Italy, Spain.

Voluntary or Mandated:

Voluntary: Firm initiated