Recall Z-1071-2017 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
The Binding Site Group, Ltd.
Human 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
| Date | Jan 23, 2017 (initiated Sep 11, 2014) |
| Status | Terminated |
| Reason | Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results. |
| Root cause | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012295 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T The Binding Site, Ltd., Aug 20, 2001 |