Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 This kit is intended for qualifying human IgG su

FDA device recall Z-1069-2017 · posted 2017-01-23 · Terminated

Recall details

Recalling firm

The Binding Site Group, Ltd.

Reason for recall

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

Action taken

Binding Site sent an Important Information letter dated September 30, 2014, Customers were instructed to retain the notification for records and additional instructions with the firm stating they were updating the instructions for use. Customers with questions were advised to contact their Binding Site representative or technical.service@bindingsite.co.uk.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CFN

Distribution

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 Ri

Date initiated

2014-09-11

Date posted

2017-01-23

Date terminated

2017-05-03

Location

Birmingham, United Kingdom