Recall Z-1068-2017
The Binding Site Group, Ltd. · initiated September 11, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: All lots.
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: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1068-2017
- Initiated
- September 11, 2014
- Posted by FDA
- January 23, 2017
- Terminated
- May 3, 2017
- Product code
- CFN – Method, Nephelometric, Immunoglobulins (G, A, M)
- 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.
- Recalling firm
- The Binding Site Group, Ltd., Birmingham
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1067-2017 Class II | Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | 09/11/2014Terminated |
| Z-1069-2017 Class II | Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 This kit is…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | 09/11/2014Terminated |
| Z-1070-2017 Class II | Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | 09/11/2014Terminated |
| Z-1071-2017 Class II | Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | 09/11/2014Terminated |
| Z-1072-2017 Class II | Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | 09/11/2014Terminated |
| Z-1073-2017 Class II | MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying…Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and… | 09/11/2014Terminated |