The Binding Site Group, Ltd.: Medical Device Recall in 2017 - (Recall #: Z-1089-2017)

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 IgG4 Kit Product Code: LK009.OPT.A

Product Classification:

Class III

Date Initiated: December 23, 2016

Date Posted: February 1, 2017

Recall Number: Z-1089-2017

Event ID: 76131

Reason for Recall:

A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert

Status: Terminated

Product Quantity: 9 users

Code Information:

Lot #401413

Distribution Pattern:

U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated