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U.S. Department of Health and Human Services

Class 2 Device Recall Human IgG Subclass Liquid Reagent Kit

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 Class 2 Device Recall Human IgG Subclass Liquid Reagent Kitsee related information
Date Initiated by FirmSeptember 11, 2014
Date PostedJanuary 23, 2017
Recall Status1 Terminated 3 on May 03, 2017
Recall NumberZ-1071-2017
Recall Event ID 76041
510(K)NumberK012295 
Product Classification Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
ProductHuman lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product Code: NK009.T 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
Code Information All lots.
FEI Number 3002808340
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
ActionBinding 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.
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = CFN
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