The Binding Site Group, Ltd.: Medical Device Recall in 2017 - (Recall #: Z-1069-2017)

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 lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents Product Code LK009.CB

Product Classification:

Class II

Date Initiated: September 11, 2014

Date Posted: February 1, 2017

Recall Number: Z-1069-2017

Event ID: 76041

Reason for Recall:

Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.

Status: Terminated

Product Quantity: N/A

Code Information:

All lots.

Distribution Pattern:

Worldwide Distribution - US including n FL, OH, TN, MN, NW, MI, CA. and Internationally to Canada, France, UK, Spain, Germany, Czech Republic, Belgium, Italy, Australia, Brazil, Chile, China, Costa Rica, Kuwait, New Zealand, Oman, Pakistan, Portugal, Sweded, Taiwan, and Turkey.

Voluntary or Mandated:

Voluntary: Firm initiated