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Class 2 Device Recall Human IgG Subclass Liquid Reagent Kit |
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Date Initiated by Firm |
September 11, 2014 |
Date Posted |
January 23, 2017 |
Recall Status1 |
Terminated 3 on May 03, 2017 |
Recall Number |
Z-1070-2017 |
Recall Event ID |
76041 |
510(K)Number |
K090920
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Product Classification |
Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
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Product |
Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 and Hitachi Modular P
Product Code LK009.H/LK001.H 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
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Code Information |
All lots. |
Recalling Firm/ Manufacturer |
The Binding Site Group, Ltd. 8 Calthorpe Road Birmingham United Kingdom
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Manufacturer Reason for Recall |
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
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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
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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.
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510(K) Database |
510(K)s with Product Code = CFN and Original Applicant = THE BINDING SITE, LTD.
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