Recall Z-1069-2017— The Binding Site Group, Ltd.
Class II · Terminated
Class II FDA medical device recall by The Binding Site Group, Ltd., initiated 2014-09-11, terminated 2017-05-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 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.CB. Reason: Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results..
- Recalling firm
- The Binding Site Group, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-11
- Terminated
- 2017-05-03
- Firm location
- Birmingham, N/A, United Kingdom
Product description
Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 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.CB
Reason for recall
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.