CLASS II Device recall · Reported 1 Feb 2017 · FDA Enforcement Report
Human lgG Subclass Liquid Reagent Kits recalled
The Binding Site Group is recalling Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product, distributed nationwide in the US. The recall was initiated on 11 Sep 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1072-2017
- FDA event ID
- 76041
- Recalling firm
- The Binding Site Group, Birmingham, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Sep 2014
- FDA classified
- 23 Jan 2017
- Reported
- 1 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 11 Sep 2014 | Recall initiated by company | |
| 23 Jan 2017 | Classified by FDA | +865 days |
| 1 Feb 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Is Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product recalled?
Yes. The Binding Site Group recalled Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product on 11 Sep 2014. The recall is Class II and its status is Terminated. Recall number Z-1072-2017.
Why was it recalled?
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Which lots are affected?
All lots.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from The Binding Site Group
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|---|---|---|---|---|---|
| Device | CLASS II | Exent Analyser recalled by The Binding Site Group | The Binding Site Group | Potency & Assay | Nationwide |
| Device | CLASS II | Freelite Human Lambda Free Kit (for use on the Spaplus) recalled | The Binding Site Group | Other | 13 states |
| Device | CLASS II | Freelite Human Kappa Free Kit recalled by The Binding Site Group | The Binding Site Group | Other | Nationwide |
| Device | CLASS II | Optilite Freelite Mx Kappa Free Kit recalled by The Binding Site Group | The Binding Site Group | Other | 10 states |
| Device | CLASS II | Optilite Optilite Rheumatoid Factor Kit recalled | The Binding Site Group | Lead & Heavy Metals | 20 states |
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|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |