FDA Device recall Z-1072-2017
Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T This kit is intended for qualifying huma…
- FDA Device
- Class II
- terminated
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class II recall of Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T This kit is intended for qualifying huma… 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-1072-2017 |
| 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 lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.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.
Other recalls by The Binding Site Group
- Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXE…
FDA Device · Class II · 2026-06-17 · The Binding Site Group - Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018…
FDA Device · Class II · 2021-12-01 · The Binding Site Group - FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK0…
FDA Device · Class II · 2021-07-14 · The Binding Site Group - Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
FDA Device · Class II · 2021-02-10 · The Binding Site Group - Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
FDA Device · Class II · 2020-06-03 · The Binding Site Group
All The Binding Site Group recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1072-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.