FDA Device recall Z-1071-2017
Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product Code: NK009.T This kit is intended for qualifying hum…
- FDA Device
- Class II
- terminated
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class II recall of Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product Code: NK009.T This kit is intended for qualifying hum… by The Binding Site Group, citing customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1071-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-11 |
| Published | 2017-02-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | The Binding Site Group |
| Distribution | CA, FL, MI, MN, OH, TN |
Product
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
Reason
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Identifiers
| code_info | All lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1071-2017%22
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