The Binding Site Group, Ltd.: Medical Device Recall in 2017 - (Recall #: Z-1043-2017)

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:

Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.

Product Classification:

Class II

Date Initiated: July 5, 2016

Date Posted: January 25, 2017

Recall Number: Z-1043-2017

Event ID: 76048

Reason for Recall:

Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to this batch will see results >114mg/L giving lower results and conversely when switching to the next batch results will be seen to shift upwards.

Status: Terminated

Product Quantity: 809 kits

Code Information:

Lot #405566, 405567

Distribution Pattern:

U.S. distribution to the following; AR, PA, GA, NC, KY, VA, CA. Foreign distribution to the following; Uk, Germany, France, Italy, Spain, Czech Republic, Portugal, Belgium.

Voluntary or Mandated:

Voluntary: Firm initiated