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U.S. Department of Health and Human Services

Class 2 Device Recall Human IgG Subclass Kit for use on the Olympus AU Series of Instruments

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  Class 2 Device Recall Human IgG Subclass Kit for use on the Olympus AU Series of Instruments see related information
Date Initiated by Firm September 11, 2014
Date Posted January 23, 2017
Recall Status1 Terminated 3 on May 03, 2017
Recall Number Z-1068-2017
Recall Event ID 76041
510(K)Number K042152  
Product Classification Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
Product Human lgG4 Subclass kit for use on the Beckman Coulter AU"
series
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.AU
Code Information All lots.
Recalling Firm/
Manufacturer		 The Binding Site Group, Ltd.
8 Calthorpe Road
Birmingham United Kingdom
Manufacturer Reason
for Recall		 Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action 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.
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 Rica, Kuwait, New Zealand, Oman, Pakistan, Portugal, Sweded, Taiwan, and Turkey.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CFN and Original Applicant = THE BINDING SITE
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