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
FDA Recall Z-1068-2017 · Posted 2017-01-23
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Recalling FirmThe Binding Site Group, Ltd.
Recall StatusTerminated
Product CodeCFN
Date Initiated2014-09-11
Date Terminated2017-05-03
Reason for Recall
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Firm 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 [email protected].
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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