Binding Site IgG Subclass Reagent Kits Recalled for Inaccurate Results
The Binding Site Group is recalling Human IgG Subclass Liquid Reagent Kits because high IgG4 levels can cause spuriously low test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to inaccurate diagnostic results (spuriously low values) rather than direct physical injury or death, fitting the criteria for moderate severity.
Plain-English summary
The Binding Site Group, Ltd. is recalling Human IgG Subclass Liquid Reagent Kits (Product Code: NK001.T) intended for use on the Siemens BN ProSpec Analyser. The recall covers all lots of the product, which is distributed worldwide, including in the United States and various international locations.
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess, which results in spuriously low IgG4 measurements. This issue affects the accuracy of the diagnostic results for human IgG subclasses 1, 2, 3, and 4.
The recall is classified as Class II by the FDA. Users of these reagent kits should contact The Binding Site Group, Ltd. for further instructions regarding the return or replacement of the affected product.
The recalled product
- 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…
- Manufacturer
- The Binding Site Group, Ltd.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots.
Distribution
Part of a larger recall action
This product is one of 7 recalled by The Binding Site Group, Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · The Binding Site Group, Ltd.
See all →- HighEXENT Analyser marked plates as passed without performing quality control
FDA (Devices) · 2026-06-17
- HighFreelite Human Lambda Free Kit Recalled for Calibration Curve Inaccuracy
FDA (Devices) · 2021-12-01
- HighFREELITE Kappa Free Kit quality control bias recall
FDA (Devices) · 2021-07-14
- ModerateBinding Site recalls Optilite Freelite Mx Kappa Free Kits for quality control bias
FDA (Devices) · 2021-02-10
- HighBinding Site Recalls Optilite Rheumatoid Factor Kits Due to Calibrator Error
FDA (Devices) · 2020-06-03
Same hazard · inaccurate results
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
Similar recalls
- LowBinding Site IgG4 Kit Recalled for Incorrect Product Insert Information
FDA (Devices) · 2017-02-01
- HighSiemens N Antiserum to Human IgG Recall for High-Dose Performance Failure
FDA (Devices) · 2022-10-26
- ModerateBinding Site C-Reactive Protein Kit Recalled for Reagent Performance Issues
FDA (Devices) · 2020-04-08
- ModerateBinding Site Human IgM Kit Recalled for Reduced Accuracy
FDA (Devices) · 2018-11-28
- ModerateBinding Site OPTILITE IgM Kit Recalled for Potential Calibration Issues
FDA (Devices) · 2020-02-26
- HighN Antiserum to Human IgG Fails High-Dose Hook Effect Performance Standards
FDA (Devices) · 2022-10-26